Drug and medical device submission

Regulatory issues are a permanent concern in clinical research for your submission of a new compound or device to be accepted, you need to  present error-free, quality-controlled regulatory documents. Our highly- qualified regulatory team prepares, coordinates and manages all the activities associated with clinical trial submissions for companies throughout Europe.

Our services cover:

  • Medical writing of:
    • protocols
    • investigational brochures and annual updates
    • clinical study reports
    • informed consent forms
    • benefit-risk assessments reports
  • Clinical development plans
  • Medical and scientific literature reviews
  • Clinical sections of Common Technical Documents (CTDs)
  • Pharmacovigilance documents
  • Preclinical study reports, expert reports and summaries
  • Data safety monitoring boards
  • Written and tabular summaries
  • Completion of CTA forms and/or ethic committee forms
  • Discussion and meetings with competent local authorities