eSUBMISSION - EXPERTISE

ONIX EXPERT REGULATORY OPERATIONSTO SUPPORT eCTD SUBMISSIONS

ONIX is a strategic partner supporting eCTD submissions to global regulatory health authorities, to meet regulatory deadlines. Our clients benefit from our worldwide regulatory operations expertise and experience on the eCTD submissions.

Our reputation is focused on industry expertise, high quality eCTD publishing, strong communication and flexibility.

ONIX SERVICES & PRODUCTS

ONIX provides the expertise to create eCTD submissions, validate and advise companies along the process to meet the technical validation required by the authorities for the drug reviewing to begin and successfully bring products to market.

ONIX supports clients with PDF publishing and MS Word formatting, eCTD Submission Strategy, eCTD Compilation, QC Review, Technical Validation upload to the Gateways, eCTD Lifecycle Project Management and Submission Hosting.

Our eCTD Consultancy and On-Site Training along with Industry Best Practices for Regulatory Operations, assist clients on formatting of Microsoft Word and PDF Publishing and using of the ONIX CTD MS Word Template package.

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What Clients Can ExpecT from Onix

eCTD ms word & pdf formatting

eCTD

  • eCTD strategy
  • Project and timeline management for the regulatory eCTD process
  • PDF publishing of documents to eCTD submission ready
  • Word formatting of documents
  • Compilation of eCTD submissions
  • Thorough Quality Check 1 of publishing of files
  • Thorough Quality Check 2 of the eCTD submission
  • 100% validated submission transmitted to FDA, EMA, CESP, MHRA
    Gateway or Portugal portal and other regulatory authorities
  • Provide final submitted submission for archive with the successfully
    acknowledge receipts
  • Complete ONIX Key Performance Indicator (KPI) of the submission

ONIX Regulatory Operations Support Service

  • Understanding of submission structure metadata / submission type
    and details relating to the submission sequence.
  • Life Cycle Operation applicability and usage of documents in a
    submission.
  • Granularity of documents.
  • Issues related to MS Word files e.g., formatting.
  • Issue relating to PDF files e.g., embed fonts, hyperlinks and
    bookmarks set to inherit zoom / optimise.
  • Naming of files in accordance with ICH or Regional Guidance.
  • Clarification of issues encountered on validating submission.
  • Technical advice on eCTD
  • ONIX can be the eCTD technical contact for the agency
  • Europe – Centralised, Decentralised, Mutual Recognition, National Procedures, ASMF, CTA and IMPD PIP Submissions
  • USA – IND, NDA, aNDA, BLA (Incl. CRFs and Dataset) and DMFs
  • Swissmedic
  • Health Canada
  • Australia
  • ASEAN, GCC, Jordan, China and Rest of World
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