Elaboration of the development strategy by a dedicated project manager

  • Set goals: taking into account customer expectations and regulatory requirements
  • Development plan design: planning the steps
  • Development organisation: definition of the stakeholders in charge of the different project stages, of the procedure to be followed and the coordination of the activities

Identification, management and coordination of suppliers and service providers

  • Suppliers: active ingredients, excipients, packagings
  • Operational subcontractors:
    – formulation, analytical, industrial (CMO, CDMO)
    – non-clinical (in vitro and ex vivo models,
    – pharmaco-toxicological
    – clinical (CRO)

Implementation of the pharmaceutical development strategy

  • Steering of development stages:
    – formulation: pre-formulation, formulation
    – analytics: development and validation
    – industrialisation: scale-up, optimisation and
     process transfer
    – stability studies: preliminary, ICH
    – non-clinical and clinical studies: in vitro, ex vivo,
      bioequivalence study, phase I, II and III studies
  • Optimisation of the timelines throughout the duration of the project

Communication with the customer

  • Weekly conference calls, on-site meetings with operational providers in presence of the client, physical meetings at the customer’s office
  • Update reports
  • Notes on specific issues

Communication with the subcontractors

  • Technical communication with subcontractors
  • Review, comments and follow-up of the deliverables
  • Weekly conference calls, on-site meetings
  • Minutes of phone calls and physical meetings

Writing of Module 3

Company agreed by French Ministry of Research (CIR -CII)

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