ISO 13485 and cGMP compliant manufacturing
- Applied and certified quality standards are ISO 13485:2016 (equivalent to 21 CFR part 820), ISO 9001:2015 and EXCiPACT®GMP/GDP:2021
- State-of-the-art facilities including ISO7/8 cleanrooms
- Controlled and documented processes, traceability and high-quality consistency
