Team · GMP Consulting and Training
Alexander Trautmann
GMP Consulting and Training
Key areas
What Alexander stands for.
Alexander Trautmann holds a licence to practise as a pharmacist and is responsible for GMP consulting and training at A&O Pharma. He works in strategic GxP consulting, operational QM support and interim management. His areas of focus are GMP training, accompanying regulatory inspections and pharmaceutical production, as well as ISO 13485, MDR and IVDR. He also covers vaccines, in vitro diagnostics and food supplements.
- GMP consulting
- GMP training
- ISO 13485, MDR and IVDR
- Regulatory inspections
- Pharmaceutical production
- Vaccines, in vitro diagnostics, food supplements
Education
Licence to practise as a pharmacist
Responsible for 3 services
Case studies
Case studies from Alexander's areas.
Anonymised projects from the services for which Alexander is responsible.
Sponsor of clinical trials, small biotech company
From the IMPD to release, all from a single source
Active substance manufacture in a non-EU country, formulation development, analytics and QP release: a project combining almost all of our services.
Read the full case studyInnovative biotech company in the field of cancer therapeutics
Establishing a GMP manufacturing facility for peptide vaccines
A renowned research institution is setting up a manufacturing facility for personalised peptide vaccines, we support them from regulatory affairs thro...
Read the full case studyThe whole company
