Business Feasibility, Development Strategies and Conceptualization
- Review of feasibility studies from an expert perspective with insights from the industry concerning market analysis & research, critical technologies and manufacturing, clinical trials, timelines, cashflow, total cost of ownership etc.
- Final products specifications through review of regulation & market, as well as current and future trends in product development. Insights from the industry towards differentiation.
- Definition of the strategy towards efficient investment and facility/operational design. Innovation vs. Standardization, Throughput vs. Differentiation etc. Impact on technologies, process flows, products, CAPEX and OPEX.
- Conceptualization of the operations: Process flow diagrams, mass balances for the various processing steps, final products’ specifications, regulatory aspects, implementation timelines etc. Budgets
- Technology Readiness Level (TRL) assessment for critical manufacturing technologies.
- Contribution to facility conceptual layout. Fundamental Flows of personnel & materials. Clean Room & Hygienic Design.
- Conceptualization of R&D/QC laboratory, incl. analytical equipment, auxiliaries and specialized infrastructure. Budgets.