About GRP
What We Do
We are a consulting company that provides a full spectrum of tailored Regulatory Affairs, Clinical, Quality and Pharmacovigilance Services to Pharmaceutical, Medical Device, Cosmetic, and Nutraceutical companies worldwide.
Our main focus is to provide our life science clients with tailored services that meet their business needs, fit their budget and support their strategic growth globally.
Industries We Serve
Pharmaceuticals
Global Regulatory Partners Inc. (GRP) provides hands-on regulatory affairs services to pharmaceutical, biologic and generic drug companies. Services provided by GRP include, but are not limited to, Regulatory Intelligence, Regulatory Strategy, Consultation Meetings with Health Authorities, Regulatory Operations, Clinical Trial Operations, Medical Writing and Publishing, Product Registration, and Product Life-Cycle Management.,
Medical Devices
GRP provides hands-on regulatory affairs services to pharmaceutical, biologic and generic drug companies. Services provided by GRP include, but are not limited to, Regulatory Intelligence, Regulatory Strategy, Consultation Meetings with Health Authorities, Regulatory Operations, Clinical Trial Operations, Medical Writing and Publishing, Product Registration, and Product Life-Cycle Management.
Cosmetics
GRP offers a comprehensive range of services for Cosmetics and Personal Care Products (PCP) to cosmetic and nutraceutical companies. GRP cosmetics services include formulation review and assessment, labeling review, product registration (as needed) and post-marketing surveillance.
Nutraceuticals
The global Nutraceutical and Dietary Supplement markets are a rapidly growing due to changing lifestyles, increasing health concerns of consumers and a growing awareness for the need to consume healthful and nutritional foods and food supplements. GRP services include, but not limited to the review of product formulations, excipient content, nutrient content, labelling, artwork, and health claims.
Pharmacovigilance
GRP provides pharmacovigilance services to Pharmaceutical, Biologic, Medical Device, Nutraceutical and Cosmetic companies worldwide. The GRP pharmacovigilance team members have long standing industry experience and consistently deliver high quality and compliant pharmacovigilance services. These help companies optimize their products’ risk-benefit profile and help improve the safety of patients and consumers.
Quality
The GRP Quality Team helps companies develop or review their quality standard operating procedures (SOPs), implement and maintain an appropriate quality management system (QMS), and manage compliance with applicable GMP, ISO 13485, GCP, CGTP and other quality standards through their products’ life-cycle. GRP has Certified Quality Auditors who can help you prepare for FDA inspections and prepare prompt responses to inspectional observations.
Where We Are
From our Blog
How China’s NMPA Review Application for Chemical Drug Changes
On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes”GRP Blog outlines how the NMPA reviews the application after receiving it and any necessary notes when preparing the application.
China’s CDE releases Guidelines for Acceptance and Review of Chemical Drug Changes
On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes” with Information on requirements for completing a Chemical Drug Change.
Guideline for Importation Process of Vaccines in Brazil
Material organized by Procomex brings description about the vaccine importation process into Brazil.
Recent Presentations
OTC MONOGRAPH REFORM IN THE CARES ACT: FDA INITIATED SAFETY ORDERS
GRP’s presentation outlines important information FDA OTC Monograph Reform.
Responsibilities of Local Agents in China
GRP’s presentation outlines important information regarding Local Representatives and their responsibilities in China.
Overview of Pharmacovigilance in Brazil
GRP’s presentation provides an overview of pharmacovigilance system in Brazil.
