Evnia announces the successful completion of ISO 9001:2015 audit for its Authorized Representative, Clinical and Regulatory Affairs Consulting services

Evnia proudly announces the successful completion of ISO 9001:2015 certification audit for its new Authorized Representative operational branch and recertification of our well-established consulting services for Clinical Affairs and Regulatory Affairs.

Months of hard teamwork, commitment to excellence, and intensive preparation led to a zero-findings result!

Having earned a stellar reputation for providing realistic, workable solutions to our partners’ regulatory challenges, Evnia will continue to consistently develop high-quality regulatory strategies and monitor their implementation, thus supporting MedTech, Biotech, and Pharma companies to the desired outcome.

The newly certified Authorized Representative operational branch, built upon our strong foundation of regulatory experience, expands our field of activities and guarantees that manufacturers outside of Europe now have a trusted partner of high professional courtesy to act as their liaison with European Competent Authorities while concretely securing their compliance with regulatory requirements.

Why Evnia?

Because you are looking

  • for access to in-house, cross-functional, field-experienced regulatory professionals from various fields
  • to reduce the risk of non-compliance
  • to shorten your time to the market
  • for practical solutions that will prevent unnecessary costs and delays

Contact us today for an introductory discussion and make the first step towards the market!