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Dossiers and Registrations

Regulatory Documentation
  • IMPD, IB, IND, NDA, CTA, EC,
  • CTD
  • Quality Overall Summary reports
  • Briefing Packages for regulatory authorities
  • Expert reports and statements
  • Replies to regulatory authorities
  • REACH files

International Dossiers

  • Registration for pharmaceuticals (NCE’s, biologicals, vaccines, diagnostic tools and medical devices), veterinary drugs
  • Registration for agrochemicals
  • Notification for chemicals
  • Technical dossier of information for cosmetics
  • IMPD, IND and Overall Quality Summary reports for clinical trial applications
 

Registration

  • Expert reports 
  • Follow-up and discussions with appropriate competent authorities

 

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