We have successfully delivered projects to our customers within the EU and US regulatory landscape and our products and services have been reviewed and audited both directly and indirectly as a result of FDA and EU regulatory inspections. Certificates and compliancy is very important to be successful.

Certificates

Iperion is ISO certified:

ISO_NEN

 


Compliancy

Furthermore, we meet the following regulations:

  • FDA 21 CFR Part 11; electronic records & electronic signatures
  • Eudralex vol. 4 annex 11 Computerised Systems

U.S. FOOD AND DRUG ADMINISTRATION (FDA) LOGO EMA2