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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.

Selected Case Studies.

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ICSRs, Local literature screening, Regulatory intelligence
Strategic Planning case study
Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system TH
DCP, EU market authorization, regulatory strategy
DCP, EU market authorization, SmPC, Medical literature search, CMS, RMS, therapeutic indications, APIs Suppliers, Local QP, local literature searching, ICSR processing, local HA, regulatory intelligence
Medical writing, Non-clinical modules, Gap analysis
A Medical Writing project covering nine non-clinical modules (m2.4) for two products in different pharmaceutical forms and dosages.

What our clients say about us.