eCTD, RPS Best Practices

Posted By GS on Apr 14, 2009 in Agencies and Regulations

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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.