Overview

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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

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.

GRP Pharmaceutical White Papers

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:

Regulatory Strategy

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 Compliance

 

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