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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 need 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:

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Michiel Stam

Michiel Stam
+31 416 707 998

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