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.
