Reflections from the 2024 DIA RSIDM Conference
Allison Steffen The recent DIA Regulatory Submissions, Information, and Document Management (RSIDM) Conference offered many practical...
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- Mar 1
- 5 min
What are the Quality (CMC) Components of the eCTD?
Module 3, dedicated to Quality (Chemistry, Manufacturing, and Controls), is an important yet complex component of the eCTD.
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- Dec 11, 2023
- 3 min
What We Can Expect with the FDA’s ESG NextGen Project
The FDA ESG NextGen will be scalable, secure, more user-friendly, and designed to handle the full spectrum of electronic submissions.
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- Nov 2, 2023
- 3 min
FDA Study Data Validator Rules for Electronic Regulatory Submissions
FDA Validator Rules are technical criteria and guidelines applied by the U.S. FDA during regulatory submission review.
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