Regulatory and Ethics Committee Submissions

Having a solid experience in Clinical Trial Application (CTA) submissions in various regions, Biomapas provides a full-scope service in order to ensure a successful and timely start of a clinical study.

Our team is dedicated to delivering the highest quality support, providing the following services:

  • Ethics Committee and Regulatory Authority submissions;
  • Preparation of Informed Consent Forms (ICFs) in line with local requirements;
  • Translation of all study-related documents into local languages, including quality check;
  • Compilation of initial submissions, amendments, notifications and close-out submissions.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

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