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Regulatory Intelligence.

Knowledge is power.

What is Regulatory Intelligence in pharmacovigilance?

Regulatory Intelligence in pharmacovigilance refers to the collection and analysis of regulatory information that can have a current or future implication on development or marketed medicinal products and devices.

As the regulatory landscape is constantly changing, knowing what governments and regulatory authorities are changing in areas such as guidance, GxP regulations and standards, submission procedures and MAH responsibilities, and what that might mean for a client’s products, is an essential activity to keep those products compliant in each market.

Our Regulatory Intelligence services?

Our expert team and partner network continually screen for these changes around the world to provide a fast and efficient interpretation and assessment of them for their impact on procedures and strategy as a part of minimizing your risk.

Our well documented and communicated analysis allows our clients to anticipate and respond to these changes in a timely manner and stay one step ahead.

What our clients say about us.

Selected Case Studies.

Selected Case Studies.

ICSRs, Local literature screening, Regulatory intelligence
Strategic planning for effective results.
Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system.
Medical writing, Non-clinical modules, Gap analysis
Delivering on our promise: ‘faster time to market’.