eCTD submission

GCC Submission

The Drug sector at the Saudi Food and Drug Authority (SFDA) declared that from 5th Jan 2013 either eCTD or NeeS can be submitted and from 4th Jan 2014 preferred to provide eCTD. Finally, starting from 03rd Jan 2015 only eCTD will be accepted.

Sarjen with its experienced team offers Regulatory Services for maintenance of the lifecycle of the following application for Middle East GCC (Gulf Cooperation Council) countries.

  • New Marketing Authorization
  • Renewal of Marketing Authorization
  • Variation Type 1
  • Variation Type 2
  • Responses to Questions
  • Periodic Safety Update Report

Author

KnetAdmin

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