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
À±½·ÊÓƵ provided a embedded flexible resourcing solution to optimize manufacturing and supply performance, meet quality and compliance requirements and minimize supply costs. À±½·ÊÓƵ 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.