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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.

Understanding the Periodic Benefit-Risk Evaluation Report

Understanding the Periodic Benefit-Risk Evaluation Report

How careful preparation of the initial PBRER sets up future success

The International Conference of Harmonization ICH-E2C (R2) requires all license holders of new medicinal products to submit a Periodic Benefit-Risk Evaluation Report (PBRER). Gain insight about best practices that can be implemented during the process of creating an initial PBRER.

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Spotlight on regulatory reforms in China

Spotlight on regulatory reforms in China

China’s regulatory reforms have attracted many foreign companies to conduct clinical trials and register their medicinal products in China. However, the evolving regulatory environment and country-specific requirements present significant challenges.

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Early engagement and regulatory considerations for biotech

Early engagement and regulatory considerations for biotech

What companies must consider when developing an asset and the importance of regulatory strategy

Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner.

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Seeking parallel consultation from regulators and HTAs in Europe

Seeking parallel consultation from regulators and HTAs in Europe

Understanding and meeting the evidence requirements of regulators and HTA bodies can be complex. Early engagement can help. Read the whitepaper for key factors to ensure that parallel consultation meetings are well prepared, productive and informative.

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The key to success under MDR and IVDR

Early planning: The key to success under MDR and IVDR

The European Union’s new Medical Device Regulation (MDR) came into effect on 26 May, 2021, and In Vitro Diagnostic Device Regulation (IVDR) will come into effect one year later. These new directives will bring:

  • Elevated clinical requirements
  • Re-classified and up-classified devices
  • A changing role of notified bodies, leading to bottlenecks and delayed timelines.
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Stay current on country, regional and global regulatory changes with ICON’s monthly Regulatory Intelligence Newsletter. It will keep you up to date with global regulatory changes that could impact your product.

Our experts review, interpret and summarise the latest regulatory developments so that you can spend more time taking your product to market. 

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