Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

MAA programme manager

For a global pharmaceutical company to register an oncology product via the European Centralised Procedure

The expertise of BioVentures Consulting Limited in progressing late-stage development programs was sourced by a global pharmaceutical company to manage all nonclinical, clinical, CMC and regulatory activities in order to register an in-licensed product via the EU Centralised Procedure. A global project plan was constructed based on cross-functional input (and area in which BioVentures Consulting Limited has considerable experience) which clarified the risks and steps needed to attain a successful MAA. Data gaps of the in-licensed product were assessed and studies designed which would be needed to fulfil the designated strategy. Budget was requested and resource acquired to deliver the MAA. BioVentures Consulting Limited worked with the client’s in-house project team members over a 9-month period to achieve a successful submission dossier.

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