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Regulatory intelligence

Regulatory experts partnering with you

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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The significant role of a robust regulatory intelligence process in global safety submissions

The significant role of a robust regulatory intelligence process in global safety submissions

Pharmacovigilance insights on the efforts towards the international standardisation of electronic transmission of drug safety information to achieve a unified objective of patient safety, written by Arinder Sihota and Trupti Gurjar, which featured in the March 2020 edition of Pharma Focus. 

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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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What clinical holds and pauses mean for COVID-19 countermeasure timelines

What clinical holds and pauses mean for COVID-19 countermeasure timelines

ICON’s Nuala Murphy and David Morse discuss trial pauses and clinical halts after three high-profile COVID-19 trials are temporarily halted as a result of potential safety issues being flagged by independent Data and Safety Monitoring Boards. Read more in this Biocentury article.

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MDR regulations

Going through changes

ICON's Angela Brown considers what manufacturers can learn from medical device regulation (MDR) and the effect it will have on the in vitro diagnotic landscape (IVD).

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Challenges associated with new EU MDR and IVDR

Challenges associated with new EU MDR and IVDR

The key challenges associated with the new EU MDR and IVDR in this article in Med-Tech Innovation News.
 

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The Need for New Business Models under MDR/IVDR

The need for new business models under MDR/IVDR

A thought leadership article on the approaching deadline for the new medical devices regulation (MDR) & in vitro diagnostic device regulation (IVDR).

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