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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Type II variation

For a medium sized pharma company

A medium sized pharmaceutical company engaged the services of BioVentures Consulting Limited to compile and submit a Type II variation relating to an improved delivery system for a product previously approved by the European Medicines Agency through the Centralised Procedure. Relevant data was assessed and interpreted in order to compile the documentation and Application Form for the submission. The application followed the timetabled process, including responses to Agency questions. The assignment resulted in a successful approval which allowed the client to then implement its wider life-cycle management strategy.

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