The world of electronic regulatory submissions is a quickly evolving and ever changing field. Submission of compliant applications in a timely manner is a key to the successful development of drugs, biologics, and devices. Traversing the myriad of old and new regulations, guidances, and variations across regions can be quite complex, particularly in light of recent initiatives, such as eCTD, SPL, PLR, PIM, ESG, etc...

Why Sage Templates?

•    Comply with eCTD granularity
•    Comply with ICH/FDA guidance for PDF documents for eCTD submissions
•    OneVoice™ dossiers
•    Authoring efficiency & consistency
•    Enforce company standards and conventions

Sage Templates Features:

•    Instructional text to guide authors in preparing content
•    Macro-Free™
•    Security
•    Support
•    Compatibility with MS Word 2000/2003/2007
•    Toolbars for common functions
•    One-keystroke action for common formatting functions
•    Encourages compliance with Agency guidance
•    Symbols toolbar
•    PK toolbar
•    All variations of eCTD granulari

For more information, please contact us.

(source: www.sagesubmissions.com )