Search and Selection of CMO - CDMO
The Selection
During a first workshop, we specify your needs and requirements, put them in contact with our CMO / CDMO database in order to determine a first list of potential CMOs. Axys-Network works on this list before returning to a second workshop to determine a short-list. Additional support may be considered (audits, etc.)
Workshop 1
- Agenda and project management
- Requirements: process, product, customer requirements, technology transfer
- Filing strategy
- Distribution of responsibilities between the client company and the CMO
- Search criteria and scoring
- Development of a first list of CMOs
- RFI draft
At Axys-Nework
- Analysis of RFI responses
- Reputation Survey of Possible CMOs
- Implementation of a short CMO list with evaluation (2-3 CMO)
Workshop 2
- Short list review - Pro's and Con's
- CMO audit program
- Aligning quality cultures
- Analytical transfer and equipment
- Intellectual property issues
- Technology transfer strategy
- CMO AUDIT
- QMS & Compliance
- Risk-based audit of the CMO's
- QMS & Compliance
Workshop 3
- RFP
- Quality Agreement
- Contract
Other services
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