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Accelerating Your Pharma Business
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
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