Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Global project manager

Biologics Licence Application of a neurology product for a medium sized biopharmaceutical company

Stephen Rees lead the client’s global project team consisting of key cross-functional CMC, non-clinical, clinical and regulatory members from the End of Phase II FDA meeting through to the successful submission of an eCTD Biologics Licence Application to the US FDA. A global Gantt plan was constructed and actively managed day-by-day to achieve an on-time delivery through the identification and management of critical path activities and project risks.

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