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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.
What We Do
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.
Industries We Serve
From our Blog
As per the Announcement no. 36 of 2021, lists requirements for voluntary submission of domestic Class III and imported Class II and III medical devices and IVDs.
The new regulations on cosmetics in china are coming into effect on May 1st, 2021. They include new classification of cosmetic product, new requirements for the ingredients, labeling, safety assessment and animal testing.
The indication for use is for mild and moderate Covid-19 cases in adults and pediatric patients (12 years and older) with laboratory-confirmed infection.