Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Renewal of MA licences

For a medium sized pharma company

The services of BioVentures Consulting Limited were engaged to compile and submit a renewal application of two marketing authorisation licences. The first was for two products in women’s health which had been approved via the European Centralised Procedure. The assignment included the compilation of the Clinical Overview (which was subsequently approved by the client’s medical head of therapy area) and the Quality Overview. BioVentures Consulting Limited also worked with the external contract agency responsible for conducting the linguistic changes in the 24 EU languages for the patient information leaflet and SmPC. The second was for the renewal of a marketing authorisation for an osteoporosis product which had been approved via the MRP. Both applications resulted in positive renewal opinions.

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