New Medicinal products (Drugs, Medical Devices, Cosmetics) in parallel to the final product design and validation stages will be submitted to the FDA, Eu and Israeli health authorities. Various official documents will be required based on the relevant regulation and standards in order to open new international markets for the Drug/Cosmetic product/ Medical Device. The desired outcome is the final marketing approval. New Drug/ Medical Device/ Cosmetic product submission and registration process require deep regulatory knowledge and experience. Each new Medicine submission process is unique and should be planned accordingly. Well planned, efficient and professional submission and registration process will focus on detailed risk assessment in order to apply the proper and shortest regulatory path.
Bio-Chem team support companies from Israel and all over the world.