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