- EU CTA preparation and submission (Eudract number obtained.) EC preparation and submission.
- US IND preparation and submission. International CTA preparation and submission (all regions - CEE, MENA, LATAM, Asia/Pac.)
- Expert advice (therapeutic areas, markets to undertake trial, filing strategies, Orphan indication, Paediatric indication (PIP))
- Scientific Advice or Protocol Advice (clinical or quality, agency meetings, advice application procedure, Orphan indication, Paediatric indication (PIP)) - US and EU agencies.
- GCP Audits
- Reports required for submission dossier CTD Mods 2 & 5 - expert assistance
- Respond to any questions and incorporate any amendments during CT process.
