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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 WE SERVE
Pharmaceuticals, Medical Devices, Cosmetics, Nutraceuticals, and Food Supplements.
GLOBAL REACH, LOCAL PRESENCE AND EXPERTISE
Local offices in USA, Asia, Latin America, and Europe.
Where We Are
What We Do
Industries We Serve
Pharmaceuticals
Global Regulatory Partners Inc. (GRP) provides hands-on regulatory affairs services to pharmaceutical, biologic and generic drug companies. The GRP regulatory team has many years of experience helping companies develop and register their products in different markets in compliance with local regulations, in record time, and with minimal risk. 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. The GRP regulatory team has many years of experience helping companies develop and register their products in different markets in compliance with local regulations, in record time, and with minimal risk. 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’s team of professionals ensure that your products meet the latest safety regulations applicable to your product before being commercialized and used by consumers. 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 has a team of experts who help Nutraceutical and Dietary Supplement companies worldwide to register and commercialize their products in compliance with local regulations. 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 has the required skills, experience and certifications to assist pharmaceutical and medical device companies attain and remain in compliance with the required quality standards. 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.
About GRP
Who We Are
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 neutraceutical 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.
Our team of professionals has decades of experience in Regulatory Affairs, Clinical, Quality and Pharmacovigilance, and has helped many life science companies register their products successfully and efficiently in USA, Latin America, Europe and Asia.
From our Blog
New Fees and Requirements for the Registration of DMFs of APIs in China
On March 2020, the Chinese health authority NMPA increased the registration fee of DMFs for APIs and added new registration requirements.
Global Regulatory Partners is Joining the Fight Against Coronavirus (COVID-19)
Global Regulatory Partners is Supporting the Fight Against Coronavirus (COVID-19) -Contact US to Learn More
FDA Emergency Use Authorization (EUA) for Face Masks Intended for a Medical Purpose, Surgical Face Masks and N95 Respirators
To increase the availability of Face Masks Intended for the protection of health care professionals the FDA will expedite the review of unapproved devices under the Emergency Use Authorization (EUA) process.
Anvisa Clarifies on use of Chloroquine and Hydroxychloroquine as potential treatments of COVID-19
ANVISA clarifies that there are no conclusive studies proving the use of hydroxychloroquine and chloroquine as a treatment for COVID-19.
Do You Qualify for FDA Emergency Use Authorization (EUA) for Coronavirus (COVID-19)?
If you are a Medical Device, or Pharmaceutical that has the potential to diagnose or treat Coronavirus, you may qualify for FDA Emergency Use Authorization (EUA) in USA.
FDA publishes guidance on conduction clinical trials during COVID-19 Pandemic.
On March 18, 2020, FDA made widely available a new Guidance Document on managing clinical trials during the COVID-19 pandemic.
