Externalized Supply Operations Management

  • Integrated, complex project and relationship management
  • Interface management between partners involved in pharmaceutical CMC development, manufacturing, testing and release as well as distribution services
  • Strong track record in international, cross-cultural project and relationship management
  • Primary and secondary manufacturing, clinical and commercial supply chain: identification, selection and qualification of potential contractors, RFP/SOW and costing assessment, contractual terms and conditions (quality agreements, development and supply agreements)


Quality Systems Implementation and Management

  • cGMP quality system design and implementation, cGMP compliance and enforcement
  • Vendor qualification and follow-up audits, for-cause audits, PAI preparation and support
  • Batch disposition documentation review, manufacturing documentation review (protocols, batch records, release documentation, change controls, deviations), stability programs consolidation and evaluation


CMC Regulatory Services

  • Writing of regulatory documentation packages supporting clinical development programs (IMPD, IND) or registration (CTD Module 3 and QOS: MAA, NDA, BLA) files
  • Submissions for the obtention of Certificates of Suitability with the European Pharmacopoeia monographs (CEP)
  • Interaction (written and meetings) with regulatory authorities (EMA, FDA, MHRA, EDQM) throughout all clinical development and registration stages
  • Compliance audits and successful support to site inspections (FDA)


Specialized Technical Expertise

  • Complex, synthetic or biological active (bio)pharmaceutical ingredients and corresponding drug product manufacturing activities (peptides, oligonucleotides, highly active and cytotoxic NCEs, biosimilars and vaccine)
  • Aseptic liquid fills (vials, PFS) and lyophilized fills (vials)
  • R&D, manufacturing and technology transfer projects: project definition, integration and management (project compliance, scope creep prevention and overall project management, “person in the plant” concept
  • Process development, scaling-up, validation, criticality assessments
  • Process changes, cost/benefit assessment and recommendation
  • Process and technology transfers


Corporate Support Activities

  • Special projects including cGMP audits, mock PAI and CAPA plans management
  • M&A support: technical capabilities, IP portfolio and industrial capability evaluations
  • Interim process development and technical operations divisions leadership
  • Reorganization or restructuration projects
  • Business continuity plan

Should you need more information, please contact us.