Drug Pipeline Approval and Commercialisation

  • Accelerated Compliant Clinical and Commercial Product Development, Regulatory Approval and Commercialisation of Late Stage Phase II & III/IV Drug Products
    • Specialising in Difficult to Develop and Commercialise Drug Candidates
  • PAI Preparation for FDA and EU Drug Approvals
    • Manufacturing Process & Analytical Development Storyboard Development to Guide Site SME FDA/EU Approval Process
    • 5052B Program Management Specialty
    • Dossier Strengthening
    • Technical Team SME preparation and ruggedness assessment prior to external scrutiny
  • Validation/Continued Process Verification for Commercial Manufacture, Launch and Ongoing Supply Chain Management
    • Robust Commercial Manufacturing and Analytical Site Capability Development
  • Process Characterisation and Optimisation including PAT Technology Design and Implementation in Partnership with Pharma Biotech Engineering Expertise
    • Locking in the Commercial Process for Ongoing Robust Quality Supply
  • Assessment of the Drug Product Pipeline in Terms of Incoming Value to the Site/s
    • Valuation of the Pipeline
    • Activity Assessment of the Pipeline
      • Anticipating Resource Capacity Constraints and Requirements across the Organisation
        • Organisational Shape
        • Facility and Technology
        • Human Resource and Skills