New Product Authorizations for Pharma - Finished Products

Freyr is a preferred Regulatory Affairs partner for new market authorizations / initial submissions to global clients, for all types of products (New Chemical Entity (NCE) / New Biological Entity (NBE), Generics / Biosimilars, Medical Devices, Active Pharmaceutical Ingredient (API) / Bulk Drugs, Over the Counter (OTC) / Consumer Healthcare products) and formulations (solid oral, liquid oral, parenteral dosage forms, biologicals etc.). Freyr has a very strong Regulatory team having prior experience and expertise in handling market authorizations of all major HAs like, the United States Food and Drug Administration (US FDA), the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines (EDQM), the Therapeutic Products Database (TPD), the Pharmaceuticals and Medical Devices Agency (PMDA), the Therapeutic Goods Administration (TGA), Medsafe, the Medicines Control Council (MCC), Ministry of Health (MoH) of Russia, Latin America (LATAM), Middle East and North Africa (MENA), Asia Pacific (APAC), Association of Southeast Asian Nations (ASEAN), Commonwealth of Independent States (CIS) regions, and World Health Organization (WHO).

Regulatory Market Authorizations