Team · Founder and Managing Director
Dr. Olaf Mundszinger
Founder and Managing Director
Key areas
What Olaf stands for.
Dr Olaf Mundszinger heads A&O Pharma and is Qualified Person (QP) under § 14 AMG. He studied pharmaceutical sciences and chemistry and holds a doctorate in analytical chemistry. Within the company, he is responsible for batch release, document preparation, interim management and strategic GxP consulting. His areas of focus are quality control and quality assurance, investigational medicinal products, solid dosage forms, process transfer and the risk assessment of elemental impurities under ICH Q3D. He also serves as the person responsible for narcotics.
As Qualified Person (QP) under § 14 AMG, Olaf holds a role that the Medicines Act (AMG) requires by name. This responsibility can neither be delegated nor spread across a team: it is on the paper that releases the batch to the market.
- Pharmaceutical quality control and quality assurance
- Person responsible for narcotics
- IMPD preparation
- Pharmaceutical analytics
- Risk assessment of elemental impurities under ICH Q3D
- Process transfer
- Solid dosage forms
- Investigational medicinal products
Education
Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry
Responsible for 6 services
Case studies
Case studies from Olaf's areas.
Anonymised projects from the services for which Olaf is responsible.
Sponsor of clinical trials, small biotech company
Active substance from a third country, release for the clinical trial
A sponsor without its own QP needed GMP oversight for manufacture in a non-EU country, the IMPD and release of the investigational medicinal product,...
Read the full case studySponsor 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 studyLarge international pharmaceutical company
Method transfer and EU retesting for launch from a third country
Analytical method transfer to our laboratory, EU retesting, import and warehousing with a logistics partner. Launch planned for 2027.
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 studyMid-sized company. Marketing authorisation holder and pharmaceutical entrepreneur
Qualified Person (QP) and Head of Production provided
Following a personnel shortage, our appointed persons secured batch release and the QM system, and business operations continued without interruption.
Read the full case studyMedium-sized company. Contract manufacturer of medicinal products
Batch release after EU import for a Swiss contract manufacturer
Continuous release of commercial medicinal products following import into the EU, plus advice on changes and operational QM support.
Read the full case studyThe whole company
