Regulatory Affairs

Local expertise in Regulatory Affairs

Encorium offers experience and local expertise to meet client needs, ensuring compliance with ICH, FDA and EMEA standards. In each country where we implement a clinical trial, we are staffed by native research professionals aware of cultural issues that may result in start-up delays and who are well-acquainted with day-to-day changes in the regulatory environment. Our services include preparation, submission and management of applications for Clinical Trial Authorisations to competent authorities and ethics committees. We ensure that all submission documentation we produce comply with all local regulatory requirements and guidelines.

Our understanding of local regulatory issues assists us in proactively addressing regulatory obstacles and minimizing regulatory delays, potentially shortening the time it takes to bring your drug to market

Contact Us

For enquiries on Encorium's services and capabilities, please contact info@encorium.com alternatively contact your local Encorium operations (see the site location map).

Encorium Headquarter

Encorium Oy
Keilaranta 10
FI-02150 Espoo
Finland
Tel: +358 20 751 8200
Fax:
Clinical Department
+358 20 751 8250
Administration
+358 20 751 8255
info@encorium.com