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United Kingdom, Windsor

Company Overview

ONIX specialises in eSubmission (eCTD / Nees / Paper)  working with organisations across the world. ONIX undertake the process of compiling, validating and submitting dossiers in eCTD format to the relevant authorities, ensuring we never miss a deadline or receive a eCTD technical rejection.
We have vast experience of:  
  • FDA (IND, BLA, NDA, aNDA, including Datasets / CRFs and DMF)
  • MAA (CP, DCP, MRP & National), ASMF, CTA, ODD, PIP
  • Swissmedic, Health Canada, TGA, ASEAN, GCC and Rest of World
  • MS Word template and formatting of Word files
  • PDF files for eCTD compliance

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