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NDA / CTD Services

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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.

This includes:

  • 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