BIOSIMILAR
PRODUCT REVIEW
Client: Top 10 European Pharma Company
Project Value: £12,550
A major pharmaceutical company, based in Europe, faced a challenge in review and update of a Module 3 and Quality Overall Summary for a Biosimilar product (IFN) in preparation for a European submission.
The product was planned to be submitted via the Centralised procedure according to stringent Company deadlines, prior to which a pre-submission meeting was planned.
The client turned to Pharmalink.
