Regulatory information management
Fast and informed decision making
enabled by process-driven regulatory information management solutions
Regulatory information management has become increasingly challenging. Regulatory Affairs needs to keep up with high and complex regulatory standards to improve patient’s benefit-risk ratio. There are a growing number of cross-functional use cases for regulatory information. At the same time, there is the need to improve operational efficiency by moving from paper thinking to electronic thinking using the latest digital technology. These challenges require regulatory information to be reliable, available and transparent. However, most regulatory departments still manage their processes and workflows in an isolated manner, using disconnected data and systems.
Create transparency and access to regulatory information
We offer our extensive domain knowledge combined with our passion for digital transformation to build transparent Regulatory Information Management solutions. At the core are seamless processes of value added steps which result in verified, reliable and non-conflicting information. Data, documents and dossiers continue to play a key role, but are managed in a way which enables reuse for different purposes (without rework by others).
Topics include, but are not limited to:
- Adoption of processes for right-first-time management of data, documents and dossiers
- Definition of user- and business requirement specifications
- Vendor selection and implementation of regulatory information management systems, including registration tracking systems, eCTD publishing tools and document management systems
- Data migration
- Validation of tools/processes