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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Antibody development

Programme director for a medium sized antibody development company

One of Europe’s leading antibody development companies secured the services of BioVentures Consulting Limited to manage the clinical and CMC components of a clinical Phase 3 antibody development programme, including primary and secondary antibody production (both at external manufacturing facilities) and the regulatory support for a Biologics Licence Application. We lead the project team and the science debate required to generate the technical documents for Module 2, such as the overall quality summary. BioVentures Consulting Limited also lead the clinical team responsible for summarising data from the pivotal Phase 3 trials required for the clinical summary documents, and coordinated across all functions to develop the overall project plan. The assignment was highly successful and ended as a result of a corporate acquisition. The services of BioVentures Consulting Limited were retained by the acquiring company to take on a biomarker oncology development programme.

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