Consulting Services - are offered in the following areas of Drug Development:
CMC Development of Biopharmaceuticals, including
- Fermentation & purification process development, including scale up,
- Formulation development (liquid, freeze-dried & vaccine formulation),
- Analytical development and characterisation,
- Manufacturing of cGMP batches for Clinical Trials,
- Process Risk Assessment, Process Characterization / Process Qualification and Process Validation
- Writing/reviewing CMC sections of regulatory documents such as IMPDs, INDs and Comparability Reports
Global CMC Development Strategy and Planning, including
- Develop Integrated Project Plan (non-Clinical, Clinical, CMC, Regulatory, Commercial),
- Preparation for market supply, such as Optimization of manufacturing processes & Scale-up to achieve long-term CoGS goals, and Strategy for Launch Supply,
- Project Management,
- Technical Due Diligence activities - evaluation of development projects / manufacturing facilities
External Stakeholder Management, including
- Identification, evaluation and contract negotiation with Contract Development & Manufacturing Organizations (CDMOs) - Drug Substance and Drug Product,
- Management of all technical operations at CDMOs,
- Supporting clients in interactions / meetings with Regulatory Authorities