Hand and Globe

END TO END
REGULATORY AFFAIRS AND
COMPLIANCE SERVICES
We provide Regulatory Affairs, Clinical, Quality Audits, and Pharmacovigilance Services across the entire life cycle.

Industries

INDUSTRIES WE SERVE
Pharmaceuticals, Medical Devices, Cosmetics, Nutraceuticals, and Food Supplements.

Globe

GLOBAL REACH, LOCAL PRESENCE AND EXPERTISE
Local offices in USA, Asia, Latin America, and Europe.

previous arrowprevious arrow
next arrownext arrow

About Global Regulatory Partners Group
The GRP-Group offers end-to-end Regulatory Affairs, Clinical, Quality, Pharmacovigilance solutions to Medtech,  Pharmaceuticals, Biotech, Cosmetics and life-consumer companies to help them access new market in record time and minimum investment, while ensuring Compliance with local regulations. 

GRP Local Offices

USA
Japan
China
Brazil
Mexico
Korea

GRP Achievements

Clients
1 +
Projects
1 +
Offices World Wide
1

Customer Testimonial

Thank you, GRP team, for registering our DMF in china. Your helped us achieve a big milestone for our company. The support and the commitment of your regulatory team have exceeded our expectations and made it easier for us to communicate with NMPA the Chinese authority. All the best !
Director of Regulatory Affairs Officer- CMC- A Large European Pharmaceutical Company based in Switzerland
We have been working with Global Regulatory Partners for 5 years and we consider them as our real partner and not as a consulting company, they had submitted 3 INDs for us with FDA successfully . The GRP team performs all IND amendments and annual reporting to FDA, we don’t have to worry about not being in compliance with FDA requirements at all.
CEO of Medium Size American Pharmaceutical Company operating in Nanotechnology based in USA
After submitting our drug application to NPMA, the Chinese agency requested us to conduct a local clinical study. Finding the qualified CRO for the study management in China was very challenging process because of the language barrier and the lack of understanding of GCP and ICH requirements. We finally found Global Regulatory Partners, that has a local team of professionals in regulatory and clinical affairs in china who supported our clinical study in China, but also helped us to understand the Chinese regulations related to our product.
CMO of Large European Pharmaceutical Company based in France and Operating in Radiopharmaceuticals
I am very impressed on how quickly Global Regulatory Affairs team was able to prepare and organize a face to face consultation meeting for our company with Anvisa in Brazil, The meeting was successful and helped us to validate and conform the regulatory strategy of our device registration in Brazil.
VP of Global Regulatory Affairs, American Based Medical device Company.

From our Blog
Toxicology and Safety in Cosmetics Current Regulatory Requirements
ANVISA

Cosmetic Safety Dossier: Navigating Regulatory and International Convergence

Building a cosmetic safety dossier is no longer just a local requirement. With increasing alignment to international standards, ANVISA now demands a well-structured set of documents proving product and ingredient safety — especially for functional cosmetics. In this blog, we’ll show you how to create a robust dossier based on Brazilian regulations and global benchmarks such as ISO 16128, EU CosIng, and SCCS guidance.

Read More »
April 24, 2025
COFEPRIS x FDA What Are the Key Differences in Medical Device Regulatory Pathways
Cofepris

COFEPRIS x FDA: What Are the Key Differences in Medical Device Regulatory Pathways?

Companies looking to commercialize medical devices internationally often target two major markets: the United States and Mexico. These countries are regulated by two robust authorities — the FDA (Food and Drug Administration) in the U.S. and COFEPRIS (Federal Commission for Protection against Sanitary Risks) in Mexico — each with distinct regulatory frameworks.
Understanding the differences between FDA and COFEPRIS approval processes is essential for planning efficient market entry, minimizing risks, and reducing time-to-market. In this blog post, we provide a clear comparison of both regulatory systems, including requirements, timelines, and strategic advantages.

Read More »
April 22, 2025
PMDA Outlines Initiatives to Promote Pediatric Drug Development in Japan
Japan regulatory authority PMDA

PMDA Outlines Initiatives to Promote Pediatric Drug Development in Japan

PDMA’s report, published in Japanese in March and translated into English in April, outlines the need for action. The agency notes “growing concerns about the expansion of drug loss n Japan, where pharmaceuticals approved in the EU and the US are not being developed for Japanese patients.” The problem is particularly challenging for pediatric and orphan drugs, PMDA said.

Read More »
April 22, 2025
See More Blogs

Follow Us on Social Media

Twitter Youtube Linkedin

Copyright ©2023 Global Regulatory Partners

Contact Us!