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New Product and Market Authorization

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.
Fervor advises in deciding the best possible Strategy aligning HAs requirements and compliance

New product authorization

Market Authorizations Application (MAA)

New Market Authorizations (API)

Biosimilars Market Authorization Applications (MAAs)

Global eCTD Publishing and Submission Services

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