Our multidisciplinary regulatory team provided strategic oversight and hands-on delivery across the full BLA lifecycle.

We supported the client’s internal BLA project through ongoing participation in monthly virtual regulatory and CMC meetings, as well as quarterly face-to-face meetings in the UK. Boyds co-led the regulatory CMC team and took lead responsibility for preparing key sections across Modules 2, 3, 4 and 5 of the submission.

Our experts led the preparation and finalisation of critical components within Modules 1, 2 and 3, including the Environmental Assessment, Structured Product Labelling content, the Clinical Overview (Module 2.5), Quality Overall Summary (Module 2.3), and all drug substance and drug product sections in Module 3. In parallel, we coordinated activities for the completion of the non-clinical and clinical Modules 4 and 5.

Boyds also supported all FDA interactions, including development of the Assessment Aid template, drafting and finalising the pre-BLA meeting briefing package, and providing strategic input and regulatory representation during the pre-BLA teleconference meeting. Our team managed FDA correspondence, prepared meeting minutes, and supported responses to any potential Refuse to File notices or Requests for Information during the review process.

Throughout the engagement, we provided proactive project management and coordination, ensuring clear communication between the client, FDA, and all third parties, and driving completion of regulatory action items to maintain momentum.