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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
On September 18,2020 Brazil’s Anvisa published the RDC no. 423/2020 which deals with the extinction of the registration and migration of medical devices of risk class II to the notification regime.
China’s CDE publishes draft listing 117 drugs that will be exempt from BE studies.
Brazil’s Anvisa new standards require companies to warn about formula changes in products subject to health surveillance.
China’s NMPA updates and address some common issues faced by the Marketing Authorization Holders to submit PRER report.
NMPA announces a new revised Drug Administration Law of the People’s Republic of China effective since Dec 1, 2019.
From September,1st 2020 COFEPRIS establishes the request for appointments will be via the internet and face-to-face attention in the CIS for the entry of priority formalities.