Sandra is a specialist for Regulatory Affairs and Product Development including drugs, drug/device combination products and medical devices. She has gained experience from small to big global pharma and medtech companies with focus on preparation and submission of technical documentation for EU, USA, Russia, China and ASEAN countries.
Moreover, she is highly familiar with medical device quality systems (ISO 13485, FDA QSR), as well as pharma cGMP and GLP.
Expertise
- Injection pens
- Auto-injectors
- Patch injectors
- Pumps
- Combination products
- Regulatory Affairs
- Stability Testing
- Chemical Testing
- Change Control Management
- Biocompatibility (ISO 10993-1)