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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., is a global consulting company that provides end-to-end regulatory affairs services to pharmaceutical, biologic and generic companies. GRP Regulatory team has many years of experience in the field, and has helped many companies to develop and register their products in different markets in compliance with local regulations, at record time and with minimum risk.
Global Regulatory Partners Inc., services include, but not limited to, Regulatory Intelligence, Regulatory Strategy, Products Registration, Regulatory Operations and publishing, Medical Writing, Consultation Meeting with Health Authorities and Life Cycle Management.
Medical Devices
Global Regulatory Partners Inc., is a global consulting company that provides end-to-end regulatory affairs services to Medical Device and Artificial Intelligence (AI) companies worldwide. Despites, the rise of challenging technologies and constant changes in the regulatory environment, Global Regulatory Partners Inc., Regulatory team of expert helps companies from products’ design phase, till products’ registration and commercialization. Global Regulatory Partners Inc., services include, but not limited to, Regulatory Intelligence, Regulatory Strategy, Products Registration, Medical Writing, Consultation Meeting with Health authorities and Life Cycle Management.
Cosmetics
Global Regulatory Partners Inc., offers a comprehensive range of services for Cosmetics and Personal Care Products (PCP) to cosmetic and nutraceutical companies. Global Regulatory Partners Inc., team of professionals ensure that your products meet the latest safety regulations applicable to your product before being commercialized and used by customers.
GRP services include products’ formulation review and assessment, labeling review, products’ registration (as needed) and post marketing surveillance.
Nutraceuticals
The global Nutraceuticals and Dietary supplements markets are a rapidly growing due to the changing of people’s lifestyle, rising health concerns of consumers and growing awareness for the need of consumption of healthy foods. Global Regulatory Partners Inc., has a team of experts who helps Nutraceutical and Dietary Supplements companies worldwide to register and commercialize their products in compliance with local regulations. Global Regulatory Partners Inc., services include but not limited to the review of products’ formulation, content, labelling, artwork, nutrient content and health claims.
Pharmacovigilance
Global Regulatory Partners Inc., provides pharmacovigilance services to Pharmaceutical, Biologic, Medical Device, Nutraceutical and Cosmetic companies worldwide. Global Regulatory Partners Inc., Pharmacovigilance team have long standing industry experience and consistently deliver, high quality and compliant Pharmacovigilance services that help companies optimize their products’ risk-benefit profile, improve the safety of patients.
Quality
Global Regulatory Partners Inc., Quality Team has the required skills, experience and certifications to assist pharmaceutical and medical device companies to be and stay in compliance with the required quality standards. The team helps companies develop their quality standard operating procedures (SOPs), implement and maintain the appropriate quality management system (QMS), to be in compliance with GMP, ISO 13485,GCP, GCTP requirements through the whole products’ life cycle. Global Regulatory Partners Inc., Certified Quality Auditors can help you prepare for FDA inspections and response to 483 efficiently.
Global Regulatory Partners iCRMAX platform
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
China Expediting the Review and Approval of Drugs to Treat Life Threatening Diseases
Chinese health authority published a list with 48 orphan drugs that qualify for an expedite review process of their registration application. The 48 drugs are used for the treatment or prevention of rare and life-threatening diseases, and have alread…
FDA Waiving the Informed Consent for Minimal Risk Clinical Studies
To date, FDA requires all subjects to provide their informed consent before participating in any clinical trial, except when there are life-threatening situations or emergency research conditions.
On November 2018, FDA proposed a new rule that wil…
FDA New Pilot Program for Medical Device Conformity Assessment Accreditation
By September 20120, the US Food and Drug Administration (FDA) is planning to lanch its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment (ASCA).
ASCA Pilot Program goa…
