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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 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.
From our Blog
Anvisa instituted the Pilot Program to Expand the Quality of the National Health Products Industries, through Ordinance 680/2020. The objective is to strengthen the industries manufacturing health products classes III and IV in the country.
On October of 2020, The Medical Device Single Audit Program (MDSAP) has published a new consolidated guidance document called, MDSAP AU P0002.005 Audit Approach.
China’s Patent Linkage Measures is a draft policy addresses market approval of generic drugs and the patent status of branded equivalents.
The Certificate of Good Manufacturing Practices is the document issued by Anvisa attesting that a certain establishment complies with Good Manufacturing Practices.
China’s CDE releases guidance on the Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Injections