We provide comprehensive regulatory services to our clients in Pharmaceuticals, Biotechnology & Biosimilar products, Health Supplements, Herbal Products, Medical Devices, Cosmetics, Food and Veterinary products, which include review & preparation of dossiers in eCTD or CTD formats, submission to authorities and follow-up till the registration is complete. Our post-registration services include handling any variations and/or renewals.
We support our clients in product registrations, renewals or variations in Gulf Health Council (GHC) for GCC countries or Saudi Food and Drug Authority (SFDA).
In Medical Device sector we provide Authorized Representative services and obtain and maintain product registration on behalf of our clients. We also assist in medical device registration in Gulf Health Council (GHC).
Pharmaceuticals i.e. New Chemical Entity (NCE), Biosimilars, Generics
Health Supplements & Herbal Products
Veterinary Medicine and Animal Feed