DIA’s RSIDM 2019: Highlights from the ‘Ask the Regulators’ Sessions
Synchrogenix was well represented at DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Forum held earlier this month. One of the reasons RSIDM is such a valuable meeting...
View ArticleHealth Canada eCTD Update
Health Canada announced an update to the mandatory use of the electronic Common Technical Document (eCTD) format. As of June 1, 2019, the remainder of Division 8 regulatory activity types (human drugs...
View ArticleAttending DIA 2019? Come See Us!
DIA is an opportunity to share challenges, strategies, and other insights to advance our common goal of achieving regulatory success. As one of our valued eCTD Summit community members, we hope you'll...
View ArticleFinal Guidance Includes eCTD Implementation Date for Promotional Materials...
Final Guidance and Implementation Date The U.S. Food and Drug Administration (FDA) has released long-anticipated final guidance with the implementation date for all promotional materials submissions...
View ArticleFDA Renews Licenses for Synchrogenix’s GlobalSubmit eCTD Software
The US FDA has renewed its legacy licenses for Synchrogenix's eCTD review and validation software, GlobalSubmit REVIEW and GlobalSubmit VALIDATE for another year. The post FDA Renews Licenses for...
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