Regulatory Affairs

 

Clinical Consulting Regulatory Affairs team has dedicated resources which enable us to provide regulatory solutions to suport with a wide range of regulatory affairs encountered in preparation and throughout the conduct of each clinical trial.

 

Clinical Consulting EU regulatory experts provide intelligence and strategic insight to optimize your product’s success.

Our experience includes, but is not limited to:

  • Country selection / local regulatory consultancy and timeline guidance

  • Preparation of clinical trial authorization applications

  • Liaison with local regulatory authorities, Institutional Review Boards, and Ethics Committees in EU countreis and EMA agency

  • Creation, preparation, execution, and maintenance of regulatory documents for submission to industry sponsors, ethics committees, and regulatory authorities

 

Coordinating and preparing applications for Orphan Drug Designation:

  • Applications for importation license

  • Regulatory inspection support