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Sage Submissions is dedicated to helping you streamline the process for creating submissions for drug, biologic and medical devices. Sage Templates™, a MS Word-based tool, helps you create documents that support the global electronic Common Technical Document (eCTD) submission standard. The templates also support all FDA CDRH and Global Harmonization Task Force (GHTF) Summary Technical Documentation (STED) pre-submissions and submissions in Electronic Copy format.
Sage Templates are optimized to comply with global agency guidances and specifications for PDF files and for the content and granularity of electronic regulatory submissions. Entering required content is easy with the Sage Toolbars, which contain all of the MS Word functions you need to structure your documents and convert them to PDF. Sage Templates Self-Paced Training and Style Guide round out the software product offerings from Sage Submissions.
Sage Submissions also provides MS Word and Adobe Acrobat training, document remediation, PDF conversion, submission publishing and eCTD submission validation services.