Share page on LinkedIn

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.

Transfer of marketing authorisation

Transfer of marketing authorisation

A successful MAT application is a very complex and cross-functional activity, involving many steps that require insightful planning and execution. Good teamwork, planning, and communication between all stakeholders including any clinical research organisations (CRO) that work for the seller or buyer are critical success factors. Read the whitepaper for best practices and clear guidance on transferring medical products.

Read the whitepaper
Keeping the end in mind: key considerations for creating plain language summaries

Keeping the end in mind: key considerations for creating plain language summaries

For sponsors preparing to meet short deadlines for PLS submission, this whitepaper outlines considerations such as creating compliant templates, endpoint consistency and inclusion, and health literacy.

Read the whitepaper
Requirements & strategy considerations within clinical trial transparency

Requirements & strategy considerations within clinical trial transparency

Read the whitepaper to learn about current clinical trial disclosure (CTD) requirements, future regulatory changes, and strategies for planning for disclosure.

Read the whitepaper
Current overview of data sharing within clinical trial transparency

Current overview of data sharing within clinical trial transparency

Sponsors preparing to share their clinical documents can incorporate best practices and implementation recommendations presented in this whitepaper, including considerations for planning and basic data anonymisation strategies for protecting patient privacy while balancing data utility.

Read the whitepaper
The RACE for Children Act

The RACE for Children Act

The RACE Act requires that studies and investigations involving products that treat adult cancer must also assess the use of those products in children.

In this whitepaper, our experts examine: Key success factors for companies, challenges presented by the RACE act, and successes through collaboration.

Read the whitepaper
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities

The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities

Ensuring regulatory compliance with the PSMF

It is essential that those who hold Marketing Authorisations (MA) within the European Economic Area have an established Pharmacovigilance System Master File (PSMF), which should be ready at the time of submission of all new applications for MAs. This whitepaper assesses the effectiveness of a global PSMF and its benefits to study personnel.

Read the whitepaper
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.

Read the whitepaper
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.

Read the whitepaper
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.

Read the whitepaper
Early planning: 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.
Read more
Regulatory Intelligence newsletter

Regulatory Intelligence newsletter

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. 

Subscribe to receive newsletter

Regulatory blogs