Biologics Consulting

Biologics Consulting is a veteran, employee-owned (ESOP) regulatory consultancy founded in 1993 by former FDA officials. It provides integrated, multidisciplinary strategy and operational support for drug, biologic, device, and combination product development, boasting a track record of over 4,700 projects for clients in 58+ countries. The firm differentiates itself through a team of 65+ regulatory experts, including former FDA professionals, offering services from regulatory strategy and submission authoring to full staff augmentation. Its client-focused approach aims to de-risk development and speed market entry for innovative therapies.

Proprietary regulatory consulting methodology and integrated service model leveraging deep expertise of former FDA officials and multidisciplinary teams. Focus on regulatory strategy, submission authoring, and operational support across drugs, biologics, devices, and combination products.

Competes with large global CROs (e.g., IQVIA, Parexel) offering regulatory services, specialized boutique regulatory consultancies, and the in-house regulatory teams of large pharma. Differentiation is based on deep FDA-specific expertise, former agency personnel, employee-owned (ESOP) client alignment, and a focused, multidisciplinary approach.