To meet our customer needs, we assist them in defining the study type (based on the type of investigational product and interventions), discuss the planned submission strategy with the competent authority, complete documents essential for submission to the relevant authorities and the ethics committee, fill out the application documents as well as ensure due diligence of the entire process in order to obtain the approval for the clinical trial conduct within the time frames specified by law.

  • Consultation with the competent regulatory authority, discussion of planned submissions
  • Preparation, review, adaptation and translation of submission documents
  • Obtaining regulatory approval as well as positive opinion of Central Ethic Committee
  • Notification of local ethics committees