Europe’s EMA
Medical Devices
Health Authority:
Medical devices are products or equipment intended generally for a medical use. They are regulated by national competent authorities of the European Union (EU). Depending on the medical device category sometimes the European Medicines Agency (EMA) can also be involved in their assessment.
Medical Device Regulations:
Medical devices within the EU are currently regulated by 3 directives; the Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990), the Council Directive 93/42/EEC on Medical Devices (MDD) (1993), and the Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998).
Medical Device Registration Pathway:
Medical devices in the EU must undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. EU Member States can designate accredited notified bodies to conduct conformity assessments. The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.
More Resources:
- European Medicine Agency.
- To access more information click the ‘Read More‘ Tab.
Authorized local agent
If your company does not have a physical location in the EU, you are required to appoint an Authorized Representative, also referred to as an EC REP, to represent your company to European authorities. You must retain an EC REP if you sell your devices in Europe.
Local Agent (EC REP) Responsibilities
Your European Authorized Representative serves as a liaison between you and the national Competent Authorities (Ministries of Health). Additionally, your appointed representative will:
- Assist with certain device registrations, as required
- Be identified on your product labeling throughout Europe
- Make a current copy of your Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request
- Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your distributor.
Distributor Responsibilities
It is not recommended to appoint a distributor as your Local Agent in Europe because most distributors are not prepared to fulfill the mandatory responsibilities of the EC REP. Instead, it is better to elect an independent representative that will focus on regulatory affairs, rather than sales and marketing.
- Our experienced consultants will review your Technical File, register your medical device or IVD, as required, and respond to any questions or concerns from the Competent Authorities.
- You will have secure online access to all your documentation and regulatory information, including technical files, labeling information and symbols, language requirements, directives, guidelines, and more.
- Our vast expertise with European regulations, registering thousands of devices, facilitates a smooth and efficient registration process.
- We send frequent updates to all of our Authorized Representation clients with important regulatory updates focused on Europe.
Global regulatory partners, Inc. (GRP) can act as your local agent and provide you with the following medical/IVD services:
GRP Medical Device Services in Europe:
- Communication with the EU
- Product Registration
- Assistance with EU inspection
- Clinical Trial management
- Support Importation Process
- Organize and support Transmutation meetings.
- Recall or incident report assistance
Regulatory Strategy
Defining the right regulatory strategy to be able to navigate through the regulatory system in Europe is essential for successful product’s registration. Our qualification process ensures potential distributors are objectively evaluated based on your needs. We offer the following services for medical device and IVD companies. Global Regulatory Partners, Inc. (GRP) regulatory team has the expertise in developing effective and tailored regulatory strategies for medical device companies that helped them get their products successfully registered in the EU, in timely manner and with minimal risk.
GRP medical device/ IVD regulatory strategy services in the EU:
- Identify and the latest regulatory requirements related to your medical device.
- Healthcare market in general (structure, number of hospitals, demographics, etc.)
- Competitors/competing technologies
- Profiles of market leaders
- Procurement of medical products
- Proactively identify challenges or issues that may delay the approval of your medical device in Europe.
- Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
- Propose innovative solutions and approaches to circumvent these challenges ahead of time.
- Identify the most cost-effective way to get your medical product registered in Europe
- Conclusions and Recommendations
Regulatory Affairs
Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP regulatory affairs services in Europe include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.
Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in Europe in order to successfully register and commercialize their products in Europe’s market and maximize the value of their assets.
Product registration
Classification of medical devices in Europe (EU):
Table 1: medical device classification
| Device Class | Description |
|---|---|
| Class I | The safety and effectiveness of the device can be ensured through routine administration. |
| Class II | Further control is required to ensure the safety and effectiveness of the device. |
| Class III | The device is implanted into the human body; used for life support or sustenance; or pose potential risk to the human body, and thus must be strictly controlled in respect to safety and effectiveness. |
European CE Marking Strategy for Medical Devices
To sell medical devices in the European Union (EU), you must obtain or apply CE Marking for your product. CE Marking indicates a product’s compliance with the applicable EU regulations and enables the commercialization of your products in 32 European countries. As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation.
CE is not a quality mark, but compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type.
European CE Marking for In-Vitro Diagnostic (IVD) devices
CE Marking is required for all in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC), and that the device may be legally commercialized in the EU.
There are four classes of IVDs:
- General IVD (Self Certified)
- Self-Testing IVD
- List B IVD (Annex II)
- List A IVD (Annex II)
While the CE process for IVDs is similar to that of medical devices, there are some key differences.
Experienced technical file preparation for IVD companies
IVD manufacturers must compile a technical file or design dossier showing compliance with 98/79/EC. Your IVD technical file must include information about your design, intended use, risk assessment, and route to conformity with IVDD requirements. Once completed, it must be made available to European Competent Authorities upon request.
CE Technical File or Design Dossier Compilation and Review
A CE Marking Technical File or Design Dossier (Class III) is a comprehensive description of your device intended to demonstrate compliance with European requirements. Compiling your technical file or design dossier is a critical step in Europe’s CE Marketing process and a requirement for compliance with the Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC.
CE Technical File and Design Dossier Requirements:
Your technical file or dossier includes detailed information about the design, function, composition, use, claims, and clinical evaluation of your medical device. They are required for all classes of devices.
(Class I, I Measuring, I Sterile, IIa, IIb and III) but no two files are the same because the type of device dictates the information included therein.
Unless you manufacture a Class I device that is not provided sterile and does not have a measuring function, your Technical File must be reviewed by a Notified Body. Understanding how to assemble this information and present it for review by Notified Bodies is essential.
GRP CE Technical File and Design Dossier compilation services:
- Help you determine exactly which materials need to be compiled.
- Completely review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s). Evaluate and identify gaps or deficiencies in your documentation.
- Compile your EU Technical File or Design Dossier, with internal peer review.
- Determine applicable testing requirements and standards for your device.
- Review your clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary.
- Review your proposed labeling and Instructions for Use.
GRP European IVD registration services:
- Act as your official Local Agent in Europe
- Identify the proper classification for your IVD
- Determine specific testing requirements for your device, along with applicable standards and MEDDEV documents
- Review existing documentation to determine compliance with Essential Requirements of 98/79/EC
- Review your existing technical file or design dossier to identify and address any gaps in your documentation
- Prepare for Clinical Evaluation Report based on provided clinical data
- Assist with Notified Body selection
- Conduct a risk assessment in accordance with EN ISO 14971:2012
- Assist with developing vigilance and post-market surveillance procedures
- Help you comply with ISO 13485 and prepare for certification audits as needed
GRP European CE market Strategy Medical Device services:
- Act as your official Local Agent in Europe.
- Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC) or Active Implantable Medical Devices Directive (90/385/EEC)
- Determine the classification of your device.
- Implement a Quality Management System if applicable to your device. Most companies use ISO 13485 to meet the requirements.
- Prepare a CE Marking Technical File or a Design Dossier
- Have your QMS and Technical File/Design Dossier audited by a Notified Body.
- Obtain CE Marking and ISO 13485 certificates from your Notified Body.
- Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive.
Clinical
Clinical trial monitoring for medical device studies
It is the responsibility of the clinical trial sponsor to ensure the safety of patients and maintain the accuracy and consistency of data collection during the trial. Our clinical trial monitors are medical device specialists and have been fully trained in Good Clinical Practice (GCP).Depending on your budget and availability of in-house resources, GRP can be involved in all or part of your clinical trial study design and protocol development.
Our clinical trial management teams have vast experience with a wide range of medical devices, including many high-risk cardiovascular, orthopedic and combination products. If your company has existing clinical resources, we can work with you to provide the clinical trial management services listed above. The ultimate goal is to reduce the time your trial takes and produce a positive outcome for the lowest possible cost.
Medical Device Clinical Trial Study Design and Protocol Development
The clinical trial protocol describes the objective, rationale, design, methodology and organization of a clinical study. Careful planning and consideration of device clinical trial study design is an important step in achieving the desired primary and secondary endpoints you desire in the most cost effective and timely manner possible.
Depending on your ultimate goal, our device clinical consulting team will work closely with you to ensure that the clinical investigation plan appropriately represents you to Institutional Review Boards (IRB)/Independent Ethics Committees (IEC) and adheres to Good Clinical Practice (GCP) guidelines, as well as all federal and local regulations.
GRP clinical trial monitoring services:
- Overseeing progress of the clinical trial to ensure the study protocol is being followed and complies with GCP and ISO 14155.
- Monitoring enrollment of qualified subjects.
- Ensuring consistency of data collection and patient treatment across multiple sites and communicating/addressing deviations from the clinical trial protocol, SOPs, GCP, etc.
- Reviewing documents to verify that reports, submissions and other documents are accurate and up to date.
- Ensuring that adverse events are reported in accordance with GCP, the protocol, Independent Ethics Committees and any regulatory mandates.
- Preparing clinical monitoring outcome reports after site visits according to established SOPs.
- Compiling final clinical study report and study master files.
GRP clinical trial protocol consultation and development services:
- Provide an Introduction which includes general information on the sponsor and investigational device, as well as background information about why the trial is being conducted, a description of the trial purpose and objectives including a statement of primary and secondary endpoints
- Produce the Clinical Investigational Plan which includes the following information:
- Study design, subject selection, inclusion, exclusion and withdrawal criteria
- Efficacy and safety assessments and variables
- Overview of trial procedures and methods of assessment
- Treatment administration, packaging and labeling, storage, subject assignment, disposition and compliance requirements
- Adverse Event (AE) reporting including definitions of adverse events, serious adverse events, device-related events, pregnancy, events of interest and collection and reporting requirements
- Statistical methods to be used, sample size, analysis plan, termination criteria, randomization methods, etc.
- Ethical considerations including a description of the role of the Independent Ethics Committee (IEC) or Institutional Review Board (IRB), ethical conduct of the study, subject information and consent
- Data quality assurance, source documentation and case report form completion, monitoring expectations, data handling, record keeping investigator training, audit/inspection procedures and handling of Personal Health Information (PHI)
- Investigator selection criteria, study completion procedures and reference list
- If applicable, Healthcare Utilization Information (HUI) collection and analysis procedures, customized appendices such as the Investigator Agreement, List of Abbreviations and Definitions of Terms, Informed Consent Form (ICF) template, etc.
Medical writing
Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Europe. As Regulatory authorities, the EU, expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.
Health authority consultation
It is highly recommended to have a pre-consultation meeting with health authorities such as with the European Union (EU) during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.
Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with the EU before starting key milestone of your product development. GRP’s regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the EU health authority, prepare the questions based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.
Quality
ISO 13485:2016 is a quality system standard designed specifically for medical device companies. It is the most commonly chosen path for companies to meet the Quality Management System (QMS) medical device requirements serves as the basis for QMS compliance worldwide.
Advantages of ISO 13485 certification:
If you manufacture or market medical devices you will need to be ISO 13485 certified. ISO certification offers many benefits for medical device companies:
- It is the “de facto” standard for global medical device QMS compliance for medical devices and is a prerequisite for access to most major markets worldwide.
- ISO 13485 certification requires effort to attain and maintain, so it gives you additional credibility and legitimacy with potential customers.
- Increased efficiency, better product quality and improved customer service within your company.
- Your commitment to quality will be evident to your consumers and partners
GRP ISO 13485 Services:
- Customization of your ISO 13485 quality system to meet your specific needs,
- Training on ISO 13485 requirements
- Ensure that your QMS is implemented on time and on budget.
- Provide qualified recommendations for third-party testing and certification firms that specialize in your category of devices.
Important change of Regulation Notice:
In May of 2017, the adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) changed the European legal framework for medical devices, introducing new responsibilities for EMA (European Medical Device Agency) and for national competent authorities.
During the transition period, manufacturers can place devices on the market under the currently applicable EU Directives (93/42/EEC, 98/79/EC and 90/385/EEC) or under the new Regulations if they fully comply with these.
Due to Covid-19 the EU has decided to delay the medical devices and IVDs transitional period.
- MDR’s have a transition period has been extended due to Covid-19 and will fully apply from 26 May 2021.
- The IVDR has a transition period of five years and will be extended from May 2023.
Pharmaceuticals
Pharmaceutical Definition:
A drug, or medicinal product in the EU, is defined “as any substance or combination of substances presented for treating or preventing disease in human beings or animals“.
Pharmaceutical Registration Pathways:
When a company wants to authorize a medicine in one or more Member States, they can use one of the following procedures:
•Decentralized– procedure where companies can apply for the simultaneous authorization of a medicine in more than one EU Member State if it has not yet been authorized in any EU country and does not fall within the scope of the centralized procedure.
• Mutual-recognition -procedure where companies that have a medicine authorized in one EU Member States can apply for this authorization to be recognized in other EU countries. This process allows Member States to rely on each other’s scientific assessments. Rules and requirements applicable to pharmaceuticals in the EU are the same, irrespective of the authorization route for a medicine.
Free Movement of Goods
It is important to note that the medicinal products in Europe are covered under a free movement of goods. The adoption of the Council Directive of 65/65/EEC on January 26, 1965, the product could be placed onto the market after the marketing authorization was granted.
More Resources:
- To access more information click the ‘Read More‘ Tab.
Authorized local agent
European authorized representative (ec REP)
If your company does not have a physical location in the EU, you are required to appoint an Authorized Representative, also referred to as an EC REP, to represent your company to European authorities. You must retain an EC REP if you sell your devices in Europe.
Your European Authorized Representative serves as a liaison between you and the national Competent Authorities (Ministries of Health). Additionally, your appointed representative will:
- Assist with certain device registrations, as required
- Be identified on your product labeling throughout Europe
- Make a current copy of your Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request
- Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your distributors
European Distributor
It is possible to appoint a distributor as your Authorized Representative in Europe, but it is not recommended because most distributors are not prepared to fulfill the mandatory responsibilities of the EC REP. Instead, select an independent representative that will focus on regulatory affairs, rather than sales and marketing.
- Our experienced consultants will review your Technical File, register your drug, as required, and respond to any questions or concerns from the Competent Authorities.
- You will have secure online access to all your documentation and regulatory information, including technical files, labeling information and symbols, language requirements, directives, guidelines, and more.
- Our vast expertise with European regulations, registering thousands of devices, facilitates a smooth and efficient registration process.
- We send frequent updates to all of our Authorized Representation clients with important regulatory updates focused on Europe.
Global regulatory partners, Inc. (GRP) can act as your local representative and provide you with the following pharmaceutical services:
GRP pharmaceutical Services in Europe:
- Communication with the EU
- Product Registration
- Assistance with EU inspection
- Clinical Trial management
- Support Importation Process
- Organize and support Transmutation meetings.
- Recall or incident report assistance
Regulatory Strategy
Defining the right regulatory strategy to be able to navigate through the regulatory system in Europe is essential for successful product’s registration with the EU. Global Regulatory Partners, Inc. (GRP) regulatory team has the expertise in developing effective and tailored regulatory strategies for medical device companies that helped them get their products successfully registered in Europe, efficiently and in timely manner.
GRP pharmaceutical regulatory strategy in Europe:
- Identify and the latest regulatory requirements related to your pharmaceutical product.
- Healthcare market in general (structure, number of hospitals, demographics, etc.)
- Competitors/competing technologies
- Profiles of market leaders
- Procurement of your drug products
- Proactively identify challenges or issues that may delay the approval of your product in Europe.
- Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
- Propose innovative solutions and approaches to circumvent these challenges ahead of time.
- Identify the most cost-effective way to get your medical product registered in Europe
- Conclusions and Recommendations
Regulatory Affairs
Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP regulatory affairs services in Europe include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.
Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in Europe in order to successfully register and commercialize their products in Europe’s market and maximize the value of their assets.
Product registration
The Common Technical Document (CTD)
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The CTD comprises of administrative information and documentation necessary to demonstrate the medicinal product’s quality, safety and efficacy. The Common Technical Document (CTD) went into force in July 2003 in all three regions (Europe, the US and Japan) covered by the International Conference on Harmonization (ICH).
It is not designed to indicate what studies are required for successful approval, but rather to indicate appropriate information organization for the application.
It is organized into five modules.
Module 1:
- The content of Module 1 was defined by the European Commission in consultation with Member State Competent Authorities, EMA and interested parties. Module 1, which consists of administrative data, is not considered a part of the CTD.
- Module 1 should provide administrative, regional or national information (e.g., the application form with 22 annexes, proposed summary of product characteristics, labelling and PIL, pharmacovigilance system description, risk management plan).
Modules 2, 3, 4 and 5 [ common for all regions]
Module 2
- contains high-level summaries and overviews (the overall quality summary, nonclinical overview and summary and clinical overview and summary) that must be prepared by suitably qualified and experienced persons (i.e., experts). The experts must sign and add brief information on their educational background and specific expertise in a special section in Module 1.
Module 3
- provides chemical, pharmaceutical and biological documentation.
Module 4
- consists of the nonclinical study reports.
Module 5
- consists of the clinical study reports.
- The applicant’s (open) part of the Active Substance Master File (ASMF) should be included in Section 3.2.S of the quality documentation presented in the CTD format.
- It is the applicant’s responsibility to ensure that the complete ASMF, consisting of the open part and the active substance manufacturer’s restricted (closed) part, is supplied to the authorities in CTD format.
- The ASMF closed part should be supplied directly by the active substance manufacturer, synchronised to arrive at the same time as the MAA (submitted by the applicant).
- An original, signed Letter of Access (LoA) addressed to the regulatory authority where the application is made must be attached to the ASMF restricted part, and a copy of the LoA must be included in Annex 5.10 of the application form in Module 1.
- The restricted part of the ASMF should follow the structure of CTD Module 3.2.S.
- A separate quality summary (2.3.S) for the information included in the restricted part should also be provided as part of the ASMF.
- Acronyms and abbreviations should be defined the first time they are used in each module.
National Procedure, Decentralized Procedure and Mutual Recognition Procedure:
Product Information
When preparing product information for Centralized Procedure, Decentralized Procedure and Mutual Recognition Procedure applications (Module 1.3.1), use of the Quality Review of Documents (QRD) convention is mandatory. The QRD working group’s mission is to ensure clarity, consistency and accuracy of medicinal product information and its translations. The group has developed product information templates to provide practical advice on how to present product information.
Additional data (might be requested) :
- Statement of MA transfer signed by both parties (Bulgaria, Greece, Hungary, Portugal, Spain) • statement on having a QP responsible for pharmacovigilance activities in the national territory where the application is made (Portugal, Romania, Spain)
- Packaging size declaration and samples declaration (Hungary, Poland)
- Contractual technical agreement between MAH and manufacturer(s) (Spain) Additional data required by different Member States are specified in Chapter 7 of NTA Volume 2A, but it is best practice to check the Competent Authority website or contact the Competent Authority via email a few months or weeks prior to submission of the MAA.
Regulatory Operations
Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in Europe. GRP’s dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.
Global Regulatory Partners Inc. (GRP) Regulatory operation services include consulting services, planning and assembly of submissions, document creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management.
GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements. GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.
Medical writing
Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Europe. As Regulatory authorities, the EU, expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.
Health Authority Consultation
It is highly recommended to have a pre-consultation meeting with health authorities such as with the European Union (EU) during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.
Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with the EU before starting key milestone of your product development.
GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the designated countries EU health authority, prepare the questions based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.
For more information on health consultations check out our resource center or contact us.
Clinical
An understanding of the regulatory requirements in Europe and experience in dealing with the local regulatory authorities EU is essential in administering a smooth, successful clinical trial in Europe. Global Regulatory Partners, Inc. (GRP) can act as your contract research organization (CRO) or help you identify a qualified CROs in Europe. Our local teams and affiliated partners located in Europe are highly experienced with the related regulatory affairs and can locally manage the full clinical trial process to ensure that it is conducted effectively and successfully.
Clinical Trials in Europe:
Clinical trials that are conducted properly in Europe facilitate a smooth registration approval process and expedite access to other global markets. If you need assistance with clinical trials for your medical product in Europe, contact us for a consultation with our regulatory experts.
GRP services for pharmaceutical companies looking to conduct clinical trials in Europe:
Clinical Trial Consulting Services
- GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
Regulatory Support
- We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in Europe. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate EU regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
Clinical Trials Management
- We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
Quality Compliance and Audits
- We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
Adverse Events and Post Market Surveillance
- We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.
Quality
Pharmaceutical Quality Systems for Drugs Products
Pharmaceutical companies are responsible for complying with EU regulations to maintain a high level of safety, efficacy and quality of their products. Compliance can be achieved by implementing a pharmaceutical quality system. Adherence to the internal PQS can ensure the identity, strength, quality and purity of drug products by requiring stringent control of every step in the lifecycle. It is important to know CGMPs only are minimum (baseline) standards. A well-designed PQS should exceed these standards
GRP’s Pharmaceutical quality assurance (QA) and regulatory affairs (RA) outsourcing services include:
- Full consulting GMP quality assurance and regulatory affairs.
- Audits of your quality management system or a supplier’s quality system.
- Review of corrective actions and recommendations for resolution.
- Supporting quality metrics and analysis as part of the management review meetings.
- Internal auditor training, risk management, quality system, or other training needs.
- Complaint handling, contract review and surveillance audits.
- Document control and maintenance of the quality system.
Cosmetics
Cosmetic Regulations:
The EU harmonized all cosmetic regulation in 2013 under Cosmetics Products Regulation (1223/2009). The harmonization process ensured all products that meet the requirements of the Regulation should have equal and immediate access to the market and should be able to circulate freely throughout the European Union.
Responsible Person:
The key principle of the Cosmetics Regulation is that the person or company who places the cosmetic product on the market, usually the importer or manufacturer, who is responsible for that product (so called ‘Responsible Person’). The Responsible Person must ensure that the product is safe and meets all the requirements of the Cosmetics Regulation. All stages of the development of the cosmetics product is regulated by the Cosmetics Regulation, from the choice of ingredients, labeling, Good manufacturing practice (GMP) to marketing and Cosmetovigilance.
More Resources:
- To access more information click the ‘Read More‘ Tab.
Authorized local agent
GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics. GRP helps manufacturers, distributors, and marketers of cosmetics in Europe. GRP can at as your Responsible Person in Europe and ensure successful product registration and approval in Europe.
GRP Cosmetic Services (Europe):
- Regulatory intelligence
- Regulatory Strategy
- Regulatory affairs
- Product Registration
- Manage Distributor
- Cosmetic packaging and labeling review
- Product classification & Formulation Review
Regulatory intelligence
GRP experts can collect the regulatory and other important requirements applicable to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in the European Market.
Regulatory Strategy
Developing the right regulatory strategy for your products in Europe crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets in Europe. Our strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals and timelines, the regulatory requirements related to your product, cost, and risk assessment. With a global presence and a local team of experts, GRP regulatory strategy will give you confidence in the forecast of key milestones, a list of the necessary documentation needed for product development and registration, timelines and cost of the different activities, and action plan to meet your milestones.
Regulatory Affairs
Global regulatory Partner, Inc. (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with the European union (EU) regulatory authorities. Our Regulatory affairs teams help cosmetic companies understand and efficiently manage the demanding complexity of the EU Regulatory requirements in order to successfully register and commercialize their products in Europe’s market.
Product Registration
Product Registration Process:
- Step 1: appointment of a Responsible Person
- Step 2: control of the product’s composition
- Step 3: creation of the Product Information File (PIF)
- Step 4: creation of compliant labels
- Step 5: CPNP notification before placing the product on the market
Safety Requirements:
Under the EU Cosmetics Regulation, companies must fulfil specific duties before placing a product on the market, must include a safety assessment (for which results must be made available for inspection), provision of product information and compliance with ingredient and labelling rules. Specifically, the Cosmetics Regulation requires safety assessments to take account of product ingredients, chemical structure and level of exposure. The safety assessment must pay attention to where the product will be applied (e.g. eyes, mouth or scalp) and which population group is expected to use it.
Global regulatory Partners, Inc. (GRP), provides end-to-end cosmetics registration services.
Cosmetic packaging and labeling review
The EU Cosmetics Regulation includes a strict set of rules for labelling of cosmetic products. Without proper labelling, a product will not be permitted onto the market. This usually falls under the responsibility if the “Responsible Person” usually the manufacturer or distributor. The distributor’s responsibilities include verifying proper labeling information, reporting possible health risks to the national authorities, and suitable storage and distribution conditions.
Global regulatory Partners, Inc. (GRP), provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate EU regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with EU requirements and the products can be used safely by the consumers. GRP can review your cosmetic packaging and labels to make sure it complies with Cosmetic Regulation standards.
Product classification & Formulation Review
In Europe, Ingredient selection and ingredient safety assessments are dictated by the EU Cosmetics Regulation. It lists all substances that must not be used owing to their toxicity, substances that can only be used in specified circumstances, and the substances approved for use in cosmetics like coloring agents, preservatives and UV filters. Preservative are also dictated in the cosmetic Regulation they are strictly governed to be included in cosmetics. Manufacturers must choose from a set list of preservatives listed in the EU Cosmetics Regulation, which have been subjected to stringent scientific tests and approval procedures before they are permitted for use, including a review by the SCCS.
Global Regulatory Partners Inc. (GRP), provides a comprehensive range of Regulatory Services related to the analysis of the list of cosmetic and PCP ingredients, the review of their formulation and labeling. GRP can review your cosmetic classification and ingredient formulation to make sure it complies with EU standards.
Nutraceuticals
Food Supplement Regulations:
In the European Union (EU), Food supplements are regulated under the European Food and Safety Authority (EFSA).The main EU legislation is Directive 2002/46/EC related to food supplements.
Food Supplement Definition:
The EU defines “food supplements” as “concentrated sources of nutrients (e.g., proteins, vitamins and minerals) and other substances that have a beneficial nutritional effect.“
The EU maintains a list of permitted vitamin or mineral substances which may be added to food supplements for specific nutritional purposes. Vitamin and mineral substances may be considered for inclusion in the lists following the evaluation of an appropriate scientific dossier concerning the safety and bioavailability of the individual substance by EFSA.
Strict EU Criteria:
The European Union has a reputation of enforcing strict rules for product claims and difficult approval process. Companies wishing to market a substance not included in the permitted list need to submit an application to the European Commission. New products originating from Europe are presumed to have passed these stricter European development and quality requirements.
GRP Services:
Global Regulatory Partners, Inc. (GRP), has a team of experts in Europe who can help Nutraceutical and food supplements companies in Europe during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.
More Resources:
- To access more information click the ‘Read More‘ Tab.
Authorized local agent
Global Regulatory Partners, Inc, (GRP) has a team of experts who helps Nutraceutical and dietary supplements companies worldwide to register and commercialize their products in compliance with the European Union (EU) regulatory requirements in terms of labelling , packaging, nutrient content claims and health claims. GRP has local offices in Europe and strategic partners worldwide who can help you register and commercialize your complementary medicine in the European market.
GRP Dietary supplements Services (EU):
- Act as your “Responsible Person”
- Regulatory intelligence
- Regulatory strategy
- Regulatory affairs
- Product Registration
- Verification of Nutrient Content Claims
- Verification of Health Claims
Regulatory intelligence
Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization in Europe. GRP experts can collect the regulatory and other important requirements applicable from the EU to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in Europe’s market.
Regulatory Strategy
Developing the right regulatory strategy for your Nutraceuticals in different markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of Nutraceuticals for the European markets. GRP strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals, your timelines, the regulatory requirements related to your product, cost, and risks.
With a global presence and a local team of experts, GRP regulatory strategy will help forecast your Nutraceutical launch and commercialization with confidence.
Regulatory Affairs
Global regulatory Partner, Inc. (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services in Europe include regulatory intelligence, regulatory strategy, labelling , packaging, nutrient content claims and health claims.
Our Regulatory affairs teams can help nutraceutical and dietary supplements companies understand and efficiently manage the demanding complexity of the EU Regulatory requirements in order to successfully register and commercialize their products in the European market and maximize the value of their assets.
Verification of Nutrient Content Claims
Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. This information helps consumers to take an informed decision about whether to purchase and consume the product or not.
Nutritional labels and packaging should include information on energy, calories, fats, sugars, proteins and salts. It is important that all this information is accurate and correct, as all nutritional details must comply with the Regulations.
In addition, the EU regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the labeling of energy drinks. Some nutrients are now prohibited to be declared. A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement.
Verification of Health Claims
Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices.
GRP team has the expertise in reviewing and validating the health claims that you are making for you nutraceutical products or dietary supplements to make sure that they are supported by scientific data, are accurate and can be accepted by EU health authorities.