TIARE CONSULTING S.L. offers the following regulatory services to pharmaceutical laboratories and technical support required for:

  • Readability test.
  • Dossiers in eCTD format.
  • Non-clinical Writing.
  • Clinical Writing.
  • Renewal of marketing authorisation.
  • PSURs.
  • Pharmacovigilance management.
  • Variations of medical products (type IA, IB or II).
  • Review and preparation a drug dossier.
  • Registration of TAC.
  • Transfer of drug dossiers.
  • Contact with Regulatory Authorities at national and international level.
  • Preparation and presentation of Drug Master File (DMF).
  • Management and CEP application.
  • Review labelling, summary of product characteristics and package leaflet.
  • Change of Technical Director.
  • Request for national codes.
  • Review advertising of medical products.