Dossiers and Registrations

• 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