Activities

 

Consulting projects

2019 - current
  • CMC/Biopharm/RA  early NCE
  • CMC/Biopharm/PK  Phase II NBE
  • DMPK   NDA
  • Biopharm-/PK-/CMC  NCE Phase I/II 
  • Business Integration

QP activities

2019 - current
  • QP for manufacturers of biologicals
  • QP for import / production of clinical trial samples and comparators
  • QP for solid oral dosage forms

Audits

2019 - current
  • GMP audit IMP-API NCE manufacturer, India
  • GMP audit IMP CMO, UK
  • GMP audit API / FF biotech manufacturer, USA
  • GMP audit QC contract laboratory, Japan
  • GMP mock audit, preparation for inspection by authorities, Germany

Training

2019 - current
  • GxP training courses at Saarland University, KIT - Karlsruhe and FSU Jena
  • QM training at the University of Potsdam
  • Business Development and R&D Training, University of Leipzig
  • CMC Training, BB Summer School, Berlin
  • Online training  Role of RA in R&D, production and marketing of drugs and medical devices