Outsourcing of Technical Writing Activities for Externally Produced Products

Challenge

A large pharmaceutical company were looking for CMC and labelling support to support a CMO consolidation exercise globally. Commercial teams had recognized huge inefficiencies in current supply chain. Their inhouse regulatory team needed support from a partner to manage the technical transfer process and increased regulatory burden as a result.

Consulting Services

Solution


Proclinical provided a embedded flexible resourcing solution to optimize manufacturing and supply performance, meet quality and compliance requirements and minimize supply costs. Proclinical staff were trained in the client’s document management systems, so the client receives submission ready documents written to a high quality. The process was managed by a dedicated Project Manager who acted as single point of control between

Outcome


  • Wave model of delivery starting with EU countries and working with local and affiliate sites to ensure regulatory documentation was ready for submission on time.
  • Client received cost savings with key outsourcing partners without needing to hire permanent staff to deliver the savings
  • Lessons learned process has helped forge further alliance with client and vendors involved.

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