European Drug Regulatory Affairs

First-rate Regulatory Affairs services for the Pharmaceutical Industry

EC drug registration

  • National, Mutual Recognition & Decentralised Procedures
  • Type I & II Variations, 5-year Renewals, Line Extensions …
  • Dossier Preparation (e.g. New Indications, Rx / OTC switch)
  • Product Packaging Materials

E-submission & dossier compilation in NeeS or eCTD format

  • Converting an existing dossier to CTD format or creating a new dossier respecting the current guidelines
  • Creation of an xml-backbone which is essential for lifecycle management
  • Dossier validation according to the latest industry standards

Regulatory Affairs Strategic advice

  • Managing Scientific-Technical Advice requests addressed to the European Medicines Agency EMA and the Europan national health authorities.
  • Identification of appropriate regulatory strategies
  • Hands-on experience to anticipate potential problems and seek out appropriate solutions

Want to know more / require a quote ?

Send your request to regulatory.affairs [at]