United States of America

Medical Devices

In the United states the Food and Drug Administration (FDA) regulates the sale of medical devices. The main regulation that defines the requirements of market authorization in the US is the Federal regulations (such as the Code of Federal Regulations, Title 21and  the Federal Food Drug & Cosmetic Act. The FD&C Act  defines Medical Devices as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

The term “device” does not include software functions excluded pursuant to section 520(o).”

Global Regulatory Partners Inc. (GRP),  can help you navigate the complex regulatory landscape of the FDA. Our teams of regulatory affairs, clinical, quality and pharmacovigilance experts  can collect the regularly intelligence develop the appropriate regulatory strategy and register successfully your medical device or IVD with FDA.

Related Links:

FDA. Medical Devices Home page. https://www.fda.gov/medical-devices

CFR-Code of Federal Regulations Title 21.  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

Federal Food, Drug and Cosmetic Act. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act

FDA product classification. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

Authorized local agent

The US Food and Drug Administration (FDA) requires all foreign medical device and IVDs manufacturers who intend to register and sell their products in the United States of America (USA) to appoint and retain a US Agent with a physical address within the USA territory. 

Global Regulatory Partners, Inc., (GRP) can act as your US agent with FDA and provide the following services:

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals, as it allows them to collect the required information related to a product, analyze it and use it to develop the appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.

Due to the continuous change of the regulatory environment, it is becoming more challenging for regulatory professionals to stay up to date of the latest regulatory requirements than can impact their products’ registration with FDA and access the US market.

Global Regulatory Partners Inc., (GRP) has a team of professionals who have the tools and expertise to collect a tailored Regulatory Intelligence for your product that includes not only the collection and analysis of all regulations that are applicable to your product but also  information on similar products on US market, to allow you develop the best regulatory strategy to develop, register and commercialize your products in US market.

Regulatory Strategy

As the US Food and Drug Administration (FDA) regulatory requirements for medical devices and IVDs keep evolving, partnering with experienced FDA consultants, such as Global Regulatory Partners Inc.,  regulatory affairs team can help you develop  the appropriate regulatory strategy for the development, registration and commercialization of your product in US market in compliance with FDA requirements.

In developing the regulatory strategy, GRP team takes into consideration different parameters such as information on competitors, product’s development status and milestones, business goals, timelines, applicable regulatory requirements, operating costs, and the assessment of potential risks that may occur during product’s development, registration or commercialization.

GRP regulatory affairs team has developed many regulatory strategies for medical device and IVD products from different therapeutic areas, that allowed medical device companies to forecast with confidence their key milestones, develop and register their products successfully with FDA and meet their business goals.

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full spectrum of regulatory affairs services, that cover all medical devices and IVDs lifecycle.

Our regulatory affairs services include regulatory intelligence, regulatory strategy, medical device and IVDs classification, registration (510(K), PMA, DeNovo), consultation meeting with FDA (pre-IDE, pre-Sub-Q) and medical writing.

Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.

Product registration

US FDA classifies medical devices and IVDs in three (3) classes based on the level of control necessary to assure their safety and effectiveness. Additionally, medical device/IVDs classification is risk based, that is, the risk the device poses to the patient and/or the user. Class I includes devices/IVDs with the lowest risk and Class III includes those with the greatest risk. The registration process of medical devices and IVDs with the FDA depends on their classification as summarized below.

Device Classification Risk Category Regulatory Controls-Registration Process
Class I Low risk General Controls
  • With Exemption (no registration required)
  • Without Exemptions (510(k) clearance required
Class II Medium risk General Controls and Special Controls
  • With Exemptions
  • Without Exemptions (510(k) Premarket Notification
Class III High risk General Controls and Premarket Approval (PMA)

Registration process of Class II Medical Devices and IVDs: 510(k) Premarket Notification

Manufacturers wishing to introduce Class II medical devices /IVDs (and a small number of Class I and III devices) to the US market must first submit a 510(k) (Premarket Notification) to the FDA and receive FDA clearance. A 510(k) is also required for manufacturers changing the intended use of their medical device /IVD or changing the technology of a cleared medical device/IVD in such a way that it may significantly affect its safety and/ or effectiveness. There are 4 types of 510(K): Traditional 510(K), Abbreviated 510(K), Special 510(K), DeNovo. To learn more about the different types of 510(K) check our white paper on “510(k) Pre-market Notification

Global Regulatory Partners, Inc., (GRP) Regulatory affairs team had prepared, submitted and cleared with FDA many 510(K)s for multiple Class II medical devices and IVDs in USA.  

Registration process of Class III Medical Devices and IVDs: Premarket Applications PMA

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure their safety and effectiveness. Therefore, they are subject to a premarket approval (PMA) application. There are three types of PMAs: Traditional PMA, Modular PMA, Product Development Protocol and Humanitarian Device Exemption. To learn more about the different types of PMAs, check our white paper on “PMAs”.

Global Regulatory Partners, Inc., (GRP) Regulatory affairs team had prepared, submitted and received the approval from FDA of many PMAs for different class III medical devices and IVDs USA.

Medical writing

Medical Writing is an important function of regulatory affairs. It consists of writing scientific, technical documents and reports of different types which include regulatory and research-related information, disease or drug-related educational and promotional literature.

FDA expects to receive precise, clear and well-written technical and regulatory documents from pharmaceutical and biologic companies. Any bad writing can raise FDA queries and consequently can delay the FDA products’ review process and approval.

 

Global Regulatory Partners Inc, (GRP) medical writers have the expertise in presenting the collected scientific information in a suitable way so it can be understood by different target audience, namely, FDA, patients or general public, physicians or the regulators. GRP Medical writers understand the medical concepts and terminology, knowledge of relevant FDA guidelines as regards to the structure and contents of specific documents, and good writing skills.

Consultation with Health Authorities

The consultation meetings with FDA for medical devices and IVDs are called “Pre-sub meetings” or “Q-Sub meetings”. These meetings allow sponsors and manufacturers to obtain FDA feedback and input on various regulatory and clinical questions related to their medical devices or IVDs, such device design as Investigational Device Exemptions (IDE) necessary for high-risk medical device clinical investigations, 510(k) submissions, and clinical or non-clinical study protocols.

The FDA Pre-sub programs are useful for devices with novel technologies, or those with indications that qualify them as “first of a kind” devices. Pre-sub meetings with FDA can be face-to-face meetings or via teleconferences with appropriate FDA personnel, or simply a written feedback.

Although Pre-Sub meeting submissions are not mandatory, medical device and IVD manufacturers are highly encouraged to do so to receive early feedback and ensure better quality of their regulatory submissions to the FDA.

Global Regulatory Partners, Inc., (GRP) Regulatory affairs team has prepared and attended many Sub-Q meeting with FDA for different medical devices and IVDs USA. To learn more about the Pre-sub/ Q-Sub meeting process, check our white paper on “Pre-Sub Meeting with FDA”.

Clinical

Global Regulatory Partners, Inc., (GRP) clinical team apply our therapeutic, regulatory, and operational expertise to consistently make sure that your clinical studies are conducted with ICH guidelines and other applicable regulatory requirements.

In an increasingly challenging environment, our clinical team has the experience and knowledge to find, recruit, and retain patients in clinical trials and successfully deliver access to the appropriate sites and patients.

Our clinical services include:

  • Protocol development
  • Clinical operations
  • Sites’ and investigators’ identification, qualification and selection
  • Site initiation and training
  • Clinical monitoring
  • Medical monitoring
  • Statistical analysis
  • Electronic Trial Master File
  • Full-service data management
  • gov registration and management
  • Clinical site quality and GCP audits

Global Regulatory Partners, Inc., (GRP) clinical team has managed many clinical studies for different medical devices and IVDs in USA in line with GCP and FDA requirements.

Quality Services

The US Food and Drug Administration requires manufacturers, specification developers, contract manufacturers, and relabels/preprocessor, and even some distributors to implement a quality system that meets the FDA Quality System Regulation (QSR) for medical devices found in 21 CFR Part 820that is similar to ISO 13485 standard for quality management systems.

The FDA does not perform a pre-registration audit for Class I and II device manufacturers, however, it performs a QMS audit prior Class III registration. Additionally, FDA conducts pre-announced inspections to medical device manufacturers to ensure their compliance to quality system requirements.

Even though FDA doesn’t require a pre-registration audit for Class I and Class II devices, companies are required by law to be following the applicable sections of the QSR before placing their device on the market. If the FDA inspect their facility and found it not in compliance, they may issue a Form 483.

Medical device companies must conduct regularly internal audits to monitor their quality management system and ensure it stays in compliance with FDA QSR requirements.

As an experienced consulting firm, GRP has helped many medical device companies comply with FDA 21 CFR Part 820 and ISO 13485 Quality Management Systems (QMS). Additionally, GRP can customize the FDA QSR quality management system to meet the client’s business needs. As its quality team doesn’t use “off the shelf” QMS solutions or QMS packaged software but create a tailored QMS for each customer that meets its business needs and complies with FDA QSR as well.

Global Regulatory Partners Quality Services include:

Gap Analysis Quality Audits

GRP certified quality auditors can perform gap analysis audits to your manufacturing sites to evaluate your current level of compliance with Quality System Management requirements as per FDA regulation 21 CFR Part 820 and ISO 13485. Gap analysis quality audits can be conducted at any time during your medical devices/IVDs lifecycle. Their main goal is to identify quality deficiencies beforehand to be able to correct them in time, before any FDA inspection or after recalls.

Full or partial internal QSR audits

FDA regulations require manufacturers to conduct regular internal audits of their quality management systems. GRP certified quality auditors can perform internal quality audits to your manufacturing sites to allow you have an independent assessment of your full or partial quality management system.

Supplier Quality Audits

As part of your full or partial QMS audits, monitoring your critical suppliers is both good business practice and a regulatory requirement. It is your responsibility to ensure proper manufacturing processes even if you rely on subcontractors for components of your manufacturing operations. GRP certified quality auditors can conduct quality audits to your main and critical suppliers to assess their compliance to QMS requirements and your products requirements.

FDA pre-inspection Audits

GRP certified quality auditors can conduct gap analysis or internal audits in anticipation of an FDA inspection or even assist during an actual FDA inspection. GRP certified quality auditors can assist you identify deficiencies in your quality system beforehand so you can address them before FDA inspections. This type of quality audits focuses on areas that may be reviewed by FDA Investigators, e.g. complaints’ handling, design control, corrective actions, manufacturing processes, special processes, etc.

FDA QSR Mock-up Audits

GRP certified quality auditors can conduct a QSR or QMS mock-up audits that mimic FDA inspections. These types of audits will help you prepare for FDA inspections and can be surprise audits as well to mimic real surprise FDA inspections.  The FDA QSR /ISO 13485 mock-up audits are performed using the FDA’s Quality System Inspection Technique (QSIT) to prepare an organization for actual FDA inspections especially after PMA submission or after a serious recall.

Pharmaceuticals

Global Regulatory Partners, Inc., (GRP), provides a full spectrum of regulatory affairs, clinical and quality services to pharmaceutical and biologic companies to allow them to develop and register their products in USA in line with FDA regulations and guidelines. GRP regulatory services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, products’ registration and products’ life cycle management. With offices in USA, GRP -USA can act as your US Agent with FDA as well.

Authorized local agent /US Agent

The US Food and Drug Administration requires foreign manufacturers who intends to register and sell their products in the United States of America (USA), to retain a US Agent with a physical address within the United States of America territory. 

In USA, GRP-US is licensed to act as your US Agent and can provide the following services: Communication with the FDA

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals, as it allows them to collect the required information related to a product, analyze it and use it to develop the appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.

Due to the continuous change of the regulatory environment, it is becoming more challenging for regulatory professionals to stay up to date of the latest regulatory requirements than can impact their products’ registration with FDA and access the US market.

Global Regulatory Partners Inc., (GRP) has a team of professionals who have the tools and expertise to collect a tailored Regulatory Intelligence for your product that includes not only the collection and analysis of all regulations that are applicable to your product but also  information on similar products on US market, to allow you develop the best regulatory strategy to develop, register and commercialize your products in US market.

Regulatory Strategy

As the US Food and Drug Administration (FDA) regulatory requirements for pharmaceutical and biologic products keep evolving, partnering with experienced FDA consultants, such as Global Regulatory Partners Inc.,  regulatory affairs team can help you develop the appropriate regulatory strategy for the development, registration and commercialization of your product in US market in compliance with FDA requirements.

In developing the regulatory strategy, GRP team takes into consideration different parameters such as information on competitors, product’s development status and milestones, business goals, timelines, applicable regulatory requirements, operating costs, and the assessment of potential risks that may occur during product’s development, registration or commercialization.

GRP regulatory affairs team has developed many regulatory strategies for pharmaceutical and biologic products from different therapeutic areas, that allowed pharmaceutical and biologic companies to forecast with confidence their key milestones, develop and register their products successfully with FDA and meet their business goals.

Regulatory Affairs

Global Regulatory Partner, Inc., (GRP) provides a full spectrum of FDA regulatory affairs services to Pharmaceutical and Biologic companies that cover the whole products’ lifecycle, starting from the development phase and going through clinical and registration phases till commercialization.

GRP regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, consultation meeting with FDA (Pre-IND, Pre-NDA), product’s registration (NDA, IND), medical writing, products’ life cycle management and maintenance.

Our Regulatory affairs teams helped many pharmaceutical and biologic companies understand and efficiently manage the demanding complexity of develop, register and commercialize their products successfully in US market and in line with FDA regulatory requirements.  

Products’ Registration

The registration process of pharmaceutical and biologic products in US is a complex and very challenging process due to the amount of pre-clinical, pharmaceutical, CMC  and clinical information that need to be included in the different modules of the registration dossier (Module 1, Module 2, Module 3, Module 4 and Module 5) to demonstrate the product‘s safety and efficacy , and also all the information must be presented and written in eCTD format.

Global Regulatory Partners, Inc., (GRP) regulatory affairs team has long-term experience in preparing, compiling and submitting to FDA registrations dossiers (IND, NDA, ANDA) for many pharmaceutical and biologics products, from different therapeutic areas, in line with FDA requirements in terms of content and format (eCTD). 

Additionally, GRP Regulatory Affairs team provide support during the FDA review process of the NDA and ANDA he registration dossiers by answering FDA queries till receiving the NDA or ANDA approval. After approval, GRP Regulatory Affairs team will maintain the approved NDAs and ANDAs by preparing and submitting amendment as needed and the annual reports. Global Regulatory Partners, Inc., (GRP) regulatory affairs team has long-term experience in preparing, compiling and submitting to FDA Drug Master Files (DMFs) for active ingredients (APIs), Excipients and Packaging Materials for many API and packaging materials manufacturers. To learn more about our DMF services, check our presentations in the resource center pages.

Regulatory Operations and Publishing

Global Regulatory Partners Inc., (GRP) offers a full electronic submission services that include consulting services, planning and assembly of e-submissions, documents creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management.

GRP Regulatory Operation team of experts ensures the quality and validity of the submissions in accordance with FDA requirements and guidelines.

Consultation with Health authorities / Consultation with FDA

Consultation meetings with FDA 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 different types of consultation meetings with FDA and with different heath authorities before starting key milestone of your product development such as

GRP regulatory affairs team supports includes: writing , preparation and submission of the meeting package to the FDA, prepare the questions to health authority based on the status of your product’s development and future plan, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.  GRP regulatory affairs team has organized and supported over 100 consultation meetings with FDA.

Medical writing

Medical Writing is an important function of regulatory affairs. It consists of writing scientific, technical documents and reports of different types which include regulatory and research-related information, disease or drug-related educational and promotional literature.

FDA expects to receive precise, clear and well-written technical and regulatory documents from pharmaceutical and biologic companies. Any bad writing can raise FDA queries and consequently can delay the FDA products’ review process and approval.

Global Regulatory Partners Inc., (GRP) medical writers have the expertise in presenting the collected scientific information in a suitable way so it can be understood by different target audience, namely, FDA, patients or general public, physicians or the regulators. GRP Medical writers understand the medical concepts and terminology, knowledge of relevant FDA guidelines as regards to the structure and contents of specific documents, and good writing skills.

Clinical

Global Regulatory Partners, Inc (GRP) clinical team apply his therapeutic, regulatory, and operational expertise to consistently make sure that clinical studies are conducted in line with FDA GCP requirements and ICH guidelines.

In an increasingly challenging environment, our clinical team has the experience and knowledge to find, recruit, and retain patients in clinical trials and successfully deliver access to appropriate sites and patients.

Our clinical services in USA include:

  • Protocol development
  • Site and investigator identification and qualification
  • Site initiation and training
  • Clinical monitoring
  • Medical monitoring
  • DSMB coordination
  • Statistical analysis
  • Electronic Trial Master File
  • Full-service data management
  • gov registration and management
  • Site quality assurance audits
  • Integrated final Clinical Study Report
  • Clinical operations.
  • IRB/Ethics approval.

Quality Services

The US Food and Drug Administration requires manufacturers, specification developers, contract manufacturers, and relabels/preprocessor, and even some distributors must implement a quality system that meets the Quality System Regulation (QSR) for medical devices found in 21 CFR Part 820. The QSR is similar to ISO 13485 standard for quality management systems, but not the same.

The FDA does not perform a pre-registration audit for Class I and II device manufacturers, however, it performs a QMS audit prior Class III registration. Additionally, FDA conducts pre-announced inspections to medical device manufacturers to ensure their compliance to quality system requirements.

Even though FDA doesn’t require a pre-registration audit for Class I and Class II devices, companies are required by law to be following the applicable sections of the QSR before placing their device on the market. If the FDA inspect their facility and found it not in compliance, they may issue a Form 483.Medical device companies must conduct regularly internal audits to monitor their quality management system and ensure it stays in compliance with FDA QSR requirements.

As an experienced consulting firm, GRP has helped many medical device companies comply with FDA 21 CFR Part 820 and ISO 13485 Quality Management Systems (QMS). Additionally, GRP can customize the FDA QSR quality management system to meet the client’s business needs. As its quality team doesn’t use “off the shelf” QMS solutions or QMS packaged software but create a tailored QMS for each customer that meets its business needs and complies with FDA QSR as well.

Global Regulatory Partners Quality Services include:

Gap Analysis Audit

Through this audit we will determine your current level of compliance with FDA regulation 21 CFR Part 820. The gap analysis can be conducted at any time on the quality system to identify deficient areas.

Full or partial internal QSR audit

FDA regulations require manufacturers to conduct regular internal audits of their quality management systems. GRP provides internal auditing services which allow for an independent review of your full quality system. We can also conduct specific QSR process audits in which we focus on specific areas of the quality system where you suspect non-compliance occurs or has occurred or focus on areas where conflicts of interest make an outside, independent GMP audit desirable.

Supplier audit

As part of your full or partial QMS audit, monitoring your critical suppliers is both good business practice and a regulatory requirement. It is your responsibility to ensure proper manufacturing processes even if you rely on subcontractors for components of your manufacturing operation. We can conduct supplier audits on your behalf to assess whether your critical suppliers are adequately addressing your requirements in accordance with applicable standards and regulations.

FDA pre-inspection audit

GRP can conduct a gap or internal audit in anticipation of an FDA inspection or even assist during an actual FDA inspection. GRP can assist you in identifying any problem areas of your quality system prior to an FDA inspection. This type of FDA audit is similar to a gap audit, but we focus on any areas that may be reviewed more intently by an FDA Investigator, e.g. complaint handling, design control, corrective action, manufacturing processes, special processes, etc.

FDA QSR mock audit

GRP can also perform a QSR audit that would mimic an FDA inspection to help the facility prepare for an actual FDA inspection. This type of audit can be done without the knowledge of the entire organization or provided as independent assessment of readiness without company personnel being aware. The FDA QSR mock audits are performed using the FDA’s Quality System Inspection Technique (QSIT) to prepare an organization for an actual FDA inspection.

Cosmetics

In United States of America, Cosmetics are regulated by the Food and Drug Administration (FDA). Cosmetic are regulated by the Federal Food, Drug, and Cosmetic Act (FD &C Act) and the Fair Packaging and Labeling Act. FDA defines cosmetics as “articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any other part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance(FD&C Act, sec 201(i)). This definition includes eye and facial makeup, perfumes, cleansing shampoo, hair colors, deodorants, permanent waves, lipsticks, and skin moisturizers.

According to the FDA, cosmetics do not need FDA premarket approval, with the exemption of color additives. It is important to note that Cosmetics’ registration in the United States is voluntary and not mandatory. However, the FDA highly encourages cosmetic firms to register their establishments and file their cosmetic product ingredients through voluntary cosmetic registration program (VCPR). It is the manufactures responsibility to ensure that their cosmetic products and ingredients are safe and properly labeled, in full compliance with the FDA laws.

Global Regulatory Partners Inc., (GRP) can help your company find the right regulatory pathway for your cosmetics in US. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and can help you register your Cosmetic product in the United States and find the appropriate local distributor for your product.

Related links:

FDA. Cosmetics. https://www.fda.gov/cosmetics

FD&C Act Chapter VI Cosmetics. https://www.fda.gov/regulatory-information/federal-food-drug-and-cosmetic-act-fdc-act/fdc-act-chapter-vi-cosmetics

Voluntary cosmetic registration program. https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program

Authorized local agent

GRP Inc. has local offices in the United States and is licensed by the FDA. GRP Inc. can act as your local agent in the United States of America for your cosmetic and Personal Care Products.

GRP Inc. Cosmetic Services:

  • Authorized local Agent
  • Regulatory intelligence
  • Regulatory Strategy
  • Regulatory affairs
  • Product Registration
  • Cosmetic packaging and labeling review
  • Product classification & Formulation Review

Regulatory intelligence

Cosmetics are regulated differently from country to country. While some countries require registration of cosmetic products others only require a notification. 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 a market.

Regulatory Strategy

Developing the right regulatory strategy for your products for 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 products and for different markets. 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. 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 regulatory authorities. Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.

Cosmetic packaging and labeling review

Global regulatory Partners, Inc., provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate region-specific regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with local and /or regional requirements and the products can be used safely by consumers.

GRP Inc. can review your products and make sure they comply with the FDA regulation for cosmetics, the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Fair Packaging and Labeling Act.

Product classification & Formulation Review

Global Regulatory Partners Inc. 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 Inc. can review your products and make sure they comply with the FDA regulation for cosmetics, the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Fair Packaging and Labeling Act.

 

Nutraceuticals

In the United States of America, FDA defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Nutraceutical claims generally fall into three categories:  health claims, nutrient content claims, and structure/function claims.  Disease-related claims are generally not permitted for nutraceuticals.

Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This regulation states that manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.  That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations. Nutraceuticals do not have to be approved by the U.S FDA prior to commercialization except for New Dietary Ingredient (NDI).

Global Regulatory Partners, Inc. (GRP), has a team of experts in USA who can help Nutraceutical and food supplements companies in US 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.

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