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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

Workshop 3

  • RFP
  • Quality  Agreement
  • Contract

Other services 

Take advantage of experienced experts and benefit from their experience

Annexe 1
Audit
Due Diligence