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