eCTD, RPS Best Practices
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0GlobalSubmit (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.
