Global Regulatory Partners, Inc.,(GRP) provides end-to-end regulatory affairs services that allow our clients register their drug, biologic or generic products in different countries at record time. Our regulatory services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, products’ registration and products’ life cycle management.
Through our local offices in USA, Latin America and Asia, GRP can act as your local authorized agent in different countries and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing vital scientific and strategic advice from products’ development till commercialization.
Authorized Local Agent
Global regulatory Partners, Inc. (GRP) has local offices and strategic partners worldwide that are licensed by local authorities to act as your local agent in many countries for your pharmaceutical products.
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.
GRP Tailored RI Services:
Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and recommendations for the commercialization of your Pharmaceutical or Biologic products in different markets.
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:
Global Regulatory Partners, Inc., (GRP) team has the expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets, that will help you meet your business needs and goals quickly and efficiently.
GRP's customized Regulatory Strategy:
In developing the regulatory strategy, GRP’s team takes into consideration different factors such as;
GRP's global presence and local team of experts:
With a global presence and local team of experts, GRP regulatory strategy will provide you the correct regulatory pathway for your product development and registration in different markets. Based on GRP regulatory strategy , you can forecast with confidence your key milestones, as you received the list of the necessary documentation needed for your products’ development and registration, the timelines and cost of the different activities, and action plan to meet your milestones.
Health authority consultation
In general, it is highly recommended to have a pre-consultation meeting with health authorities such as FDA, EMA, PMDA , ANVISA, NMPA , TGA 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.
GRP Regulatory Affairs Support Team:
GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets.
GRP regulatory affairs support team services :
Regulatory Operations and publishing:
Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in the US, European Union, Japan, China, LATAM, and ASEAN. GRPs dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.
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.
GRP Regulatory Operation services:
Medical writing involves writing scientific documents of different types which include regulatory and research-related documents, disease or drug-related educational and promotional literature.
GRP Medical Writing Services:
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, health authorities, patients or general public, physicians or the regulators. GRP Medical writers understand the medical concepts and terminology, knowledge of relevant guidelines as regards the structure and contents of specific documents, and good writing skills.
Global Regulatory Partners Inc., (GRP) offers a full service for Pharmaceutical and biologic products registration in different countries in line with local regulations. Pharmaceuticals companies, certainly those developing new technologies, quickly discover the demanding and complex regulatory process required from health authorities (HA).
GRP Global Presence and Local Team of Experts:
GRP has local teams of regulatory experts that work with worldwide health authorities (HA) constantly such FDA, EMA, NMPA, PMDA , ANVISA, COFEPRIS, CDSCO, ANMAT, TGA, and HSA.
GRP Successful Track Record:
GRP has a long history and track record in successfully preparing, compiling and submitting to HA, dossiers of pharmaceutical and biologic products from different therapeutic areas despite the complexity of their technologies.
GRP RA team will prepare and submit the responses to health authorities’ queries as needed and will provide the necessary regulatory support till you receive the formal application approval.
GRP's Submission Services:
Orphan Drug Registration
Orphan drugs are medicinal products intended for the diagnosis, prevention, or treatment of life-threatening or very serious diseases or rare disorders where human consumption may be very few.
Many countries have developed and adopted a specific regulatory framework for orphan drugs to provide a number of incentives supporting companies developing drugs for rare diseases. Although there are similarities among these regions, criteria and procedures vary.
GRP regulatory affairs and clinical team have many years of experience in defining the appropriate regulatory and clinical development strategies for orphan in different countries. The team had prepared and filed many applications for orphan drug designation (ODD) and obtained the approvals for ODD for many drugs in different countries in record time.
GRP services for Orphan Drugs:
Drug Master file registration
A Drug Master File (DMF) is a submission to health authority that is used to provide confidential and detailed information about facilities, and processes or articles used in the manufacturing, processing, packaging, and storing of one or more drugs.
The submission of a DMF is not mandatory by health authorities like FDA, EMA, Anvisa, NMPA or PMDA but it is a choice made by the holders to protect their confidential information related to their products. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.
A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application.
In Europe, USA and Canada, DMF contains two parts, the applicant’s part and the restricted part. Additionally, in these countries there are 4 types of DMFs: Type I (Manufacturing Site, Facilities, Operating Procedures, and Personnel); Type II (Drug Substance, Drug Substance Intermediate, and Material Used in their Preparation, or Drug Product); Type III (Packaging Material); Type IV (Excipient, Colorant, Flavor, Essence, or Material Used in their Preparation) and Type V (References).
- Regulatory submission strategy for different types of DMFs for drug substance (Type II DMF), packaging materials (Type III DMF) and Excipients (Type IV DMF)
- Preparation and submission of Drug Master Files in line with Health authorities
- Publishing of DMFs in eCTD format as per current US FDA guidelines and requirements
- DMF life cycle management including amendments and annual reports.
- Updating or amending existing DMFs with the USFDA
- Preparing the different documents of Module 1 required for each country.
- Converting existing DMFs to eCTD format.
- Acting at local agent and representative for DMF in USA, EU, Brazil, Japan and China.
GRP Clinical Expertise:
Our professionals apply their 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, we have the experience and knowledge to find, recruit, and retain patients in clinical trials. We successfully deliver access to appropriate sites and patients, developing strategies that will minimize the risks inherent in-patient recruitment.