pharma & biotech consultancy
Knowledge is power
+20 years of scientific experience in immunology, virology
+12 years in Drug Development
Broad knowledge of drug development from discovery throughout clinical phases of a variety of drug candidates (small molecules, biologics, vaccines and ATMP / gene therapy).
- (Cell-based) Bioassays
- HPLC / LCMS
Development, Feasibility, Qualification, Validation, Monitoring, Troubleshooting, Modernizing, GxP certified.
- Screening / Confirmatory / Neutralizing assays
Development, Feasibility, Qualification, Validation, Monitoring, Troubleshooting, Modernizing.
- Risk management strategies / Product specific risk factors
- Process development
- Tech transfer
- GAP Analysis
- Strategy Management
- Vendor selection, audit and management
- Support regulatory submissions mainly with regards to assays
- Teaching / Training