Actual activities

R&D development support for biotech project pipeline (from preclinics to clinics and beyond)
In-vitro-/In-vivo-correlation analyses and corresponding pharmaceutical development concept for generics
Due diligence for preclinics and CMC
Expert in patent litigation
CMC development support for development projects
QA-strategy in GXP environment
QP support for a biotech company and for an ISS
GXP training for several customers
GMP audit for clinical supply
Clinical supply management concepts for international studies
Vendor audits
Preparation/support of pre-approval inspections by FDA
Efficiency and change management project in QC
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actual version 02.08.2016