eCTD, RPS Best Practices

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GlobalSubmit (the company I work for) has recently enhanced its website to include a considerable amount of eCTD and RPS-related reference material. Check out our Best Practice pages for practical information on a variety of topics, including:

  • Technical Rejection Avoidance
  • eCTD Reviewing
  • eCTD Validation
  • eCTD Content
  • eCTD Readiness
  • Document Templates
  • Study Tagging Files (STFs)
  • Granularity, and Submission Outsourcing.

We have also posted links to eCTD guidelines for the US, EMEA, Health Canada, PMDA, and TGA. We also have links to HL7/Regulated Product Submission (RPS) information.

Author: GS

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