An intuitive DMS uniting Clinical, Regulatory, and Quality teams in one workspace.
Cost-effective eTMF solutions for trial management, migration, inspection and storage
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Gain efficient, compliant oversight of internal and external parties with an intelligent QMS
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Enhance clinical and regulatory document submission knowledge at your organization with industry-leading resources.
In this article, we'll walk you through what an IND is, what the application should include, and how to work alongside the FDA for maximum success.
RIM (Regulatory Information Management) refers to the effective and efficient identification, collection, curation, communication, and management of regulatory information for products...
If you have been in the industry as long as some of us, (haha) then eCTD v. 4.0 has been coming for a long time. 😉 Some agency regions are already accepting and piloting v. 4.0. For many...
The Electronic Common Technical Document (eCTD) has long been the backbone of regulatory submissions, streamlining the process of dossier submissions for marketing authorization...
In the realm of regulatory submissions, ensuring efficient document management, accessibility, and compliance is paramount. One critical tool that aids in this process is an Electronic...
Are you a regulatory leader trying to meet tight submission deadlines with distributed teams and multiple vendors responsible for various content? You are not alone. Many sponsors are...
In pharma and biotech, managing regulatory information effectively is crucial for compliance and success. An Electronic Document Management System (EDMS) provides a powerful solution to...
Emerging life science organizations often deal with authoring processes that are lengthy and complicated. Documents are difficult to format and maintain, and users often spend the bulk of...