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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
CDE releases No. 94 of 2018 stating that certain biological products maybe imported for a one- time for clinical trial purposes.
On January 17, 2020 The Center of Drug Evaluation has published a Notice on improving the relevant functions of the API registration system,
Indonesia’s Halal Product Law Criteria and a review of the halal global market and foreign company halal accreditation process