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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

BLA submission

Neurology program for a medium sized biopharmaceutical company

Due to the successful project management of a neurology program from End of Phase II FDA meeting through to completion of the pivotal clinical trials, the services of BioVentures Consulting Limited were re-engaged, this time with the important brief to lead the compilation and submission of a Biologicals Licence Application. The assignment included the management and delivery of the content of Modules 3 (including the drug substance and drug product DMFs), Module 4 and Module 5 (including the RMP); the strategic content of all Module 2 summary documents (including 2.5, 2.7 the ISS, ISE and 2.3QOS); the PIL and SmPC for Module 1, ensuring that the dossier met the pre-submission FDA meeting commitments, and that key messages in the product label accurately optimised product market positioning. This was a high-level strategically-important assignment for the client. Outputs reported through to Corporate Vice President and then subsequently to board level.

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