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REGULATORY AFFAIRS AND
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
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
The FDA’s FY 2019 GDUFA report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts.
The Emergency Approval of Novel Coronavirus Nucleic Acid Detection Reagent has shown the NMPA accelerated approval of seven NAD Reagents in only four days before going to the market.
China Health Authority CDE Cancelling Face-to-Face Meetings with Companies to Prevent the Spread of Coronavirus
On February 3, 2020 China’s CDE has taken some measures to prevent and limit the spread of corona-virus out from the city of Wuhan.