Consulting, covering upstream and downstream of biopharmaceuticals, FDA remediation projects. According to "Quality by Design" standards of the ICH, we support our customers to develop well-designed and controlled processes with a proven transferability throughout the scales from R&D to production.
Some insights
Consulting and Interim-Management for Biopharma and MedTech companies,
COVID-19 mRNA Vaccine Project:
• Tech Transfer Lead for sterile Fill & Finish operations with Key Accountability (FPOC) for CMO
• Analytical Method Transfer,
• Cross functional multinational Project Management within large teams