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. 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.
We provide global Regulatory Affairs services and consultancy covering all aspects of the preparation of submission and management of marketing authorization applications and maintenance.

This may include:

• Preparation, submission and management of applications for Clinical Trial Authorizations to competent authorities and ethics committees.
• European regulatory strategy planning and choice of procedure (centralized, decentralized, mutual recognition, national)
• Organization of pre-submission meetings with authorities
• Dossier review and EU/US “conversions”
• Adaptation of Common Technical Document formats