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pharma & biotech consultancy

expertise

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).

  • Immunoassays
  • (Cell-based) Bioassays
  • Biomarkers
  • HCP
  • HPLC / LCMS
  • Biosimilarity

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
  • Biosimilarity
  • Process development
  • Potency
  • Upscaling
  • Tech transfer
  • Analytics
  • Formulation

ADDITIONAL SERVICES

  • GAP Analysis
  • Strategy Management
  • Vendor selection, audit and management
  • Support regulatory submissions mainly with regards to assays
  • Teaching / Training
Scientia-Potentia-Consultancy-Expertise-Melody-Janssen-Sauerborn-library

Do we have a match or do you need more in depth information? Please let me know.

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