NDA / CTD Services
Eurofins CDMO (Contract Development & Manufacturing Organization) regulatory experts will draft, review and manage the necessary documents to enable the building of Common Technical Document (CTD) for product registration and life-cycle submissions.
- CTD module 3 and Quality Overall Summary in compliance with international standard (ICH guidelines, EU-EMA, USFDA, Health Canada, TGA, Asean guidelines)
- NTA part 2 and corresponding Expert report for Veterinary medicinal products.
- Advice on registration strategies during product life cycle.
- Variations and amendments to existing Marketing Authorization.
- Responses to Questions during assessment procedure.
Choose Eurofins CDMO to help you:
✔ Understand the current regulatory landscape
✔ Establish and support product- and commercially-appropriate regulatory concepts
✔ Capture and convey appropriate product and process data
✔ Draft, review and manage product dossiers
✔ Anticipate and respond to Regulators’ questions through the submission cycle
✔ Be prepared for life-cycle product management