NDA / CTD Services
Regulatory experts from Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies 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.
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Choose Eurofins CDMO network of companies 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
