Team · Investigational Medicinal Products and GCP
Dr. Lenka Taylor
Investigational Medicinal Products and GCP
Key areas
What Lenka stands for.
Dr Lenka Taylor is responsible for investigational medicinal products and GCP. She holds a doctorate in clinical analytics and is a specialist pharmacist for clinical pharmacy. At A&O Pharma, she works on Regulatory Affairs and batch release. Her areas of focus are clinical trial planning, IMPD preparation, aseptic compounding and GCP and GMP consulting and training.
- GCP and GMP consulting
- GCP training
- Clinical trial planning
- IMPD preparation
- Aseptic compounding
Education
Doctorate in clinical analytics, specialist pharmacist for clinical pharmacy
Responsible for 3 services
Case studies
Case studies from Lenka's areas.
Anonymised projects from the services for which Lenka 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 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 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 studyMid-sized company, marketing authorisation holder
Manufacturing site transfer: CMC review, transfer plan and support
Review of the marketing authorisation chapters and quality documents, risk assessments and a robust transfer plan for the planned change of manufactur...
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
