Introduction
The ENOVIA Regulatory Manager role (RIR-OC), introduced in R2025x FD03, helps Medical Device, Pharmaceutical and Biologics manufacturers to streamline and simplify the regulatory submission process. The role ensures global compliance by centralizing dossier management, automate submission planning, manage authorizations and define templates aligned with regulatory authority requirements. The solution enables end-to-end regulatory submission lifecycle management on 3DEXPERIENCE Platform by enhancing transparency, reducing risk, and accelerating time to market.
Objective
The ENOVIA Regulatory Manager role manages all the aspects of record management from a common interface illustrated below.
New Submission
Enables you to create new submissions manually or from existing templates managed and created in the application. This streamlines and standardizes the creation of all subsequent submissions. Three types of submissions can be created:
- Initial: Create a new submission manually or from a template
- Variation: Use an existing submission as the starting point for new submission which contains common information
- Renewal: Create a renewal to extend the expiry date to extend an existing valid submission
Analytics
Provides a dashboard that displays a real-time status of all active submission records in the system. Use the filter charts to display specific data using Tags or by selecting chart points to probe into specific data.
Submissions
Displays a table of all active submissions including the authorization details for the product, the regions, countries, regulatory authority, and submission type. It also includes a project plan, any associated correspondence, contact details of people relevant to the process, and a dossier.
Authorizations
Displays the maturity of each active submission (approved, effective, expired) which can be filtered and sorted
Contacts
Provides contact information, including the name, role, and email address of people relevant to your submissions.
Configurations
Displays common information for all submissions:
- Regulatory Categories: Within the regulatory categories you can manage the subtypes based on region.
- Submission Templates: Creation and management of submission templates used to streamline submission creation.
- eSignature: Set parameters to enforce an electronic signature when moving through maturity states.
- Lifecycle Authorization Scheduler: Manages the automation of expiry and renewal dates.
Summary
The Regulatory Record Management solution helps organizations streamline their regulatory processes by managing submission templates, helping in submission preparation, and ensuring compliance with global regulatory agencies. This app provides centralized dossier management, submission planning, automation, compliance assurance, and reporting capabilities, enhancing regulatory processes and optimizing operational efficiency.
