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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.

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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. 

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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.

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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.

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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.

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