Fervor 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.).
Extensive experience in managing market authorizations of all major Health Authorities such as US FDA,
EMA, EDQM, PMDA, TGA, Medsafe, SAHPRA, MoH-Russia, Latin America (LATAM), Middle East and
North Africa (MENA), Asia Pacific (APAC), ASEAN, CIS regions, and the WHO.