Achieve Data-Centricity, Digitalization and Automation in Regulatory Submissions

Regulatory Management is essential to ensure that sponsors can accurately and easily share content and collaborate with the relevant global regulators. Dassault Systemes is transforming submissions management by delivering a data driven and model-based approach to the automated generation of this critical content. Our ability to capture the essential data from the sponsors enterprise Data Lake or individual systems and generate the relevant CMC tables, charts and critical narrative is now possible. Initiatives such as KASA form the FDA mean that the industry must now leverage AI to transition away from conventional Word-based cut and paste from Lab systems.

Our CMC Authoring solution not only delivers the data, but also ensures full traceability to source, the ability to refresh the data dynamically, re-use of content between different regions/submissions, full “where-used” for all content elements, real-time collaboration across authoring groups and an unmatched ability to drive change control ad updates to CMC and other submission modules. This fully qualified Saas solution leverages state of the art AI and Structured Content Authoring techniques.

BIOVIA Regulatory Management Key Benefits

Compliance

Reduces errors caused by manual activities, ensures consistency and completeness of data and documents, ensure data traceability and “data integrity by design”, keeps up with agencies’ (FDA, EMA...) requirements including data format and reduces post-submission issues

Time and Budget

Reduces manual steps and non-value adding tasks, reduce manual data query of data in each application, eliminates repeated data verification approvals, reduce review cycles and reduces response time to authorities

Collaboration

Removes the complexity of multiple systems, collaborate simultaneously on documents, share knowledge based on structured content, formalize and harmonize internal practices and integrates new partners, suppliers and customers

A SaaS Cloud Solution

BIOVIA Regulatory Management solutions are available on the 3DEXPERIENCE platform to help deliver the benefits of a data-centric and AI-driven automated generation of documents for regulatory submission.

Key Benefits:

Accelerate document production by eliminating manual transfer (copy and paste)
Produce accurate reports through automated document generation
Maximize transparency through traceability and direct access to source data
Protect IP with a secure cloud-based collaborative environment

BIOVIA Regulatory Management solutions are packaged as Roles to get you up to speed faster and work more efficiently with all needed applications available at your fingertips. Select a package that corresponds to your role in an organization.