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Regulatory affairs

A widely acknowledged TECHNICO-REGULATORY EXPERIENCE

ICTA has been ensuring full management of the application dossiers necessary to obtain from the regulatory authorities, the authorizations necessary for the set-up of pre- and post-marketing clinical studies in France (since 1983), and in Europe, North America, Turkey, Israel and Scandinavian countries.

Our good knowledge of the legislation for health products and medical devices updated regularly by the regulatory watch of our Quality Assurance department, our understanding of the expectations from the regulatory authorities and our in-depth experience of electronic systems guarantee the compliance of our application dossiers with the applicable regulations in force, and their admissibility.

  Autorisations _EMA_FDA

CLINICAL STUDIES (MEDICINAL PRODUCTS, VACCINES, CELL / GENE THERAPIES, BLOOD BY-PRODUCTS, MEDICAL DEVICES):

  • Regulatory consultancy
  • Adaptating study documents to the required  local regulatory procedures and translating into local language
  • Obtaining import and export licensing and ensuring compliance of the labelling of the study products
  • Request for EUDRACT Number
  • Preparation and electronic submissions of CTA applications and amendments to the local Competent Authorities, Ethics Committees and IRBs
  • Preparation and submission of dossiers for the obtention of approval decisions pertaining to the protection of private data and security of information systems
  • Communication and coordination with the health authorities during the follow-up of the dossiers 
  • Regulatory follow-up during the clinical study conduct
  • Registration of studies on the regulatory websites (public directory of clinical trials, clinicaltrial.gov., etc)
  • Management of the policy of transparency: Bertrand bill (France), Sunshine act (US), Bribery Act (UK)...