BLA Regulatory

BLA Regulatory is a Boston-based, private regulatory affairs consultancy serving biotech and pharma companies globally. It leverages a team with over 130 years of combined experience, including former FDA personnel, to provide services ranging from gap analysis and health authority meetings to full application submission and clinical trial registration. The firm has a proven track record, having assisted with over 300 INDs and 50 marketing applications, and was recognized as a Top 10 Emerging Consulting Company in 2022. Its business model is entirely service-based, generating revenue through client consulting engagements.

Integrated regulatory affairs service model leveraging a team with combined experience from FDA and industry. Services include gap analysis, health authority meetings, IND/BLA/NDA filing, clinical trial registration, medical writing, and eCTD publishing.

Competes with large, full-service Contract Research Organizations (CROs) that have regulatory divisions, as well as other specialized regulatory affairs consulting boutiques. Differentiation is based on niche expertise, particularly former FDA regulator experience, personalized service, and a proven track record with INDs and marketing applications.