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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