In an increasingly demanding regulatory environment, our regulatory team is dedicated to help customers with regulatory questions and to support them with their regulatory submissions to secure their projects and
optimize time-to-market. The team is composed of regulatory affairs professionals, experienced in primary packaging components, systems and drug delivery devices. It is located in the EU and the USA.
Our experts are active members in AFNOR, DIN and ISO committees as well as contributing to the main expert groups and consortia (EPAG, IPAC-RS, PDA and others).
Most of our drug delivery devices are regulated in the USA as device components of combination drugs.(cf FDA 21 CFR 3.2)
- Over 25 year experience of supporting our customers' regulatory submissions
- Track record of 30 DMFs with US FDA
- Track record support to 30 successful NDAs and ANDAs
- Global support
- Fast approval drug delivery device data packages