Global eCTD Guidance Interpretation is a Regulatory offering from Octagon that represents hundreds of hours of cross-functional regulatory and process research, analysis and interpretation of current agency guidances and specifications compiled into one offering. The Global eCTD Guidance Interpretation (GI) is a standalone offering that complements Octagon’s other Regulatory solutions.

The Global eCTD Guidance Interpretation (GI) distills over 35 current electronic submission guidances into one user-friendly document. Included computer-based training supports implementation of the guidance interpretation. Customization of the GI and corresponding training is available from Octagon’s Process Solutions consultants. Choose from a US based GI or a combined European/Canadian interpretation.

• Provides a common framework and establishes your organizational approach to eCTD submissions
  • Offers consistency across therapeutic, geographic or functional areas
• Also used as a training tools to ensure common understanding across the organization
• As guidances change and the interpretation is updated, everyone is accessing the most current interpretation, moving in a common direction
• Provides a common foundation for the “fuzzy gray areas” where guidances lack clarity
• Complements StartingPoint, eCTD JumpStart and ViewPoint eCTD Complete
• This compilation represents over 500 hours of regulatory and process experts collaborations

Data Sheet

Case Studies