Easily manage submissions across multiple regions

Life sciences companies today are challenged by regulatory submissions processes that vary by country and region. The DXC Technology Regulatory Publishing Software Suite provides an end-to-end solution that empowers users to assemble, review, compile and publish dossiers — such as electronic common technical documents (eCTDs) and non-eCTD electronic submissions (NeeS) that meet various requirements.

Our regulatory publishing software suite is flexible, scalable and adaptable. With this solution, organizations can simultaneously publish and submit new drug applications in multiple markets and in compliance with a variety of regulatory formats. The solution increases the speed and efficiency of regulatory submissions and helps organizations deal with the challenge of working across disparate regulatory environments.

What’s New in Regulatory Publishing Suite

Bringing together powerful applications and user-friendly solutions, the latest versions of DXC Technology’s Regulatory Publishing Suite help customers improve efficiency and speed up the submission process.

Performance upgrades to eCTDXPress and Publisher simplify the creation, life-cycle management and compliance validation of eCTDs and NeeS applications across multiple regions. The latest version takes a modularized approach to document management solutions, allowing eCTDXPress and Publisher to be integrated with any new DMS, provides platform support for third-party applications and enables enhanced multi-domain support so administrators can create domain-specific accounts. Greater automation, innovation and flexibility let customers scale the solutions to meet their needs.

What's coming soon in DXC Regulatory Publishing Portfolio 

 Next Version of Publishing Suite will include:

• New regional guidance and validation criteria
• Enhanced automation and integration
• Enhanced reporting
• Platform updates
• And more to come

DXC's Regulatory Publishing Suite offerings:

eCTDXPress

eCTDXPress makes eCTD submissions faster and easier by streamlining the process: from building and compiling to validating and archiving

Publisher

DXC Publisher, a scalable solution that can be implemented on premises or in a cloud environment, can simplify the submission process.

ToolBox

ToolBox provides more than 50 plug-in tools to simplify the time-consuming tasks involved in producing and processing PDF files.