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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

PSUR / RMP

For a medium sized pharma company

A medium sized pharmaceutical company which was facing a resource short-fall at a time of pressing need to submit two PSURs and RMPs to an agreed timetable as part of the life-cycle activity for two product registered through the EU Centralised Procedure, hired the services of BioVentures Consulting Limited. A member of the BioVentures Consulting Limited team worked alongside the client’s pharmacovigilance project expert to compile the PSURs and the RMPs. The documents were proofread and critiqued for accuracy and consistency, and the PSUR was submitted to the EMA on time. The client was pleased with the quality and competency of the interaction and BioVentures Consulting Limited was asked to continue with the project and oversee delivery of the agreed FUM commitments.

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