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 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.
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
EMA waives fees for orphan drug consultations
European Medicines agency (EMA) updates their executive decision for orphan drug development of waiving fees for academic organizations.
Brazil’s Anvisa updates conduct of clinical trials with Technical Note 22/2020
Anvisa publishes a Technical Note 22/2020 updating the guidelines for sponsors, research centers and investigators involved in conducting clinical trials.
Webinar: Brazil Cosmetic Regulatory Compliance and Importation Requirements
GRP has teamed up with ChemLinked to bring you a webinar on Cosmetic Regulation and requirements in Brazil. The webinar will introduce the Brazilian cosmetic market, then specify the cosmetic regulatory framework, including cosmetics registration, labeling, and advertisement, and finally outline regulatory requirements for the importation of cosmetics into Brazil
US FDA releases its first patient focused drug development (PFDD) guidance
The US FDA has released its first patient focused drug development (PFDD) guidance. This guidance is the first methodological guidance( referred as guidance 1) and that will be followed by 3 more guidance’s on this topic.
How Cosmetic companies can stay complaint online during the COVID-19 Pandemic
The pandemic has produced new obstacles for all businesses including the cosmetic industry. the pandemic has produced a shift from shopping in stores to shopping online. the online platform is new media to many businesses and with it brings its own obstacles such as regulation requirements that differ by country.
US FDA Facilitates Intellectual Property Rights For Dietary Supplements
The US FDA proposes useful tools to register innovative dietary supplement for New Dietary Ingredient – Master file (NDI-MF).
