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Designed primarily to meet regulatory requirements for therapies targeting large patient populations, the existing development model lacks the flexibility, analytical power and efficiency to address today’s development demands. It is essential to develop a regulatory strategy plan early in drug development to identify key challenges that may arise, and interact collaboratively with regulatory authorities. This will also enable you to ensure that plan aligns with the profile and commercialisation for drug development.

COVID-19 regulatory news stories

COVID-19 regulatory updates

Governments worldwide are swiftly intervening to create alliances with pharma, biotech, diagnostics and medical device manufactureres to address the COVID-19 threat. International regulatory agencies are considering accelerated approvals, including Emergency Use Authorisations.

To stay up to date with all COVID-19 related regulatory content, visit ICON's Coronavirus Observatory. This tool utilises powerful AI analysis and data visualisation for COVID-19 news and social media including regulatory updates.

Coronavirus Observatory
Early planning: The key to success under MDR and IVDR

Early planning: The key to success under MDR and IVDR

Read the "Getting Ready for Europe’s New Rules: A Guide for Successfully Developing and Commercialising Medical Devices and In-Vitro Diagnostics under MDR and IVDR" white paper to learn how to effectively prepare for these imminent regulatory changes.

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Regulatory intelligence, medical writing and operational efficiency through automation

Webinar: Managing safety reporting in the evolving regulatory environment of Asia Pacific

This webinar will provide insight into regulatory developments in Taiwan, China, Singapore and Japan, delving deeper into the recent and upcoming safety regulations in Korea, to support understanding and compliance in pharmacovigilance. It will explore methods for keeping up to date with the latest regulatory intelligence, medical writing customisation and achieving operational efficiency through automation.

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Webinar: How to Ensure Compliance with the New EU Medical Device Regulations

Webinar: How to ensure compliance with the new EU medical device regulations

The scope and complexity of this legislation will require significant changes in areas such as product development, data reporting, quality assurance and manufacturing processes. While these dates may seem a long way off, manufacturers need to start planning immediately, as adjusting will take time and effort.

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Regulatory blogs