Team · Business Development
Sascha Manthei
Business Development
Key areas
What Sascha stands for.
Sascha Manthei is responsible for Business Development at A&O Pharma and is Qualified Person (QP) under § 14 AMG and a pharmacist. He is responsible for pharmaceutical quality management, advises on GMP and conducts audits. His range extends from investigational medicinal products to authorised medicinal products, and from sterile and solid dosage forms to biotechnological medicinal products. He also serves as the person responsible for narcotics. His work has included projects ranging from IMPD preparation through to release of an investigational medicinal product, the testing of a stored active substance for a clinical trial, and the establishment of a GMP manufacturing site.
As Qualified Person (QP) under § 14 AMG, Sascha 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.
- Qualified Person under § 14 AMG
- Pharmaceutical quality management
- GMP consulting
- Auditor
- Investigational medicinal products and authorised medicinal products
- Sterile dosage forms (aseptic, terminally sterilised)
- Solid dosage forms
- Biotechnological medicinal products
- Person responsible for narcotics
Education
Training as a bank clerk, degree in pharmacy, licence to practise as a pharmacist, Master of Business Administration (MBA)
Responsible for 3 services
Case studies
Case studies from Sascha's areas.
Anonymised projects from the services for which Sascha 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
