Regulatory Support

Regulatory Support

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, and they are 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)
 

We offer:

  • Over 25 years of global experience supporting regulatory submissions
  • A successful track record with the U.S. FDA with more than 100 approved NDAs and ANDAs, and 40 INDs in the past 5 years.