Resource Hub

Explore our collection of valuable resources, incorporating the latest news, events, regulatory intelligence, and thought leadership.

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Regulatory Intelligence

Stay current with ever-changing regulations. Utilize our comprehensive references to stay abreast of regulatory changes across a spectrum of medical topics from health authorities across the globe.

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Resources

Whitepaper

The EU Clinical Trials Regulation

This paper provides changes and updates to Clinical Trials Regulation in the EU as of December 2023.

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Whitepaper

The EU Clinical Trials Regulation

This paper provides changes and updates to Clinical Trials Regulation in the EU as of December 2023.

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Newsletter

Regulatory Intelligence of Cosmetics Jul – Sep…

Regulatory Intelligence of Cosmetics for July through September of 2023.

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Blog

Custom-Made Medical Devices: Are You Complying With…

The world is progressing rapidly with advanced technologies and customization in almost every sector to meet human needs.…

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Blog

Project FrontRunner: Advantages in directing oncology therapy…

What is Project FrontRunner? Project FrontRunner is an Oncology Center of Excellence (OCE) initiative that encourages sponsors to…

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Blog

Informed Consent: Guidance for IRBs, Clinical Investigators…

In August of 2023, the Food and Drug Administration (FDA) released a final guidance document that serves to…

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Blog

New EU MDR compliance dates: Impact assessment…

MDR transition Regulation (EU) 2017/745 on medical devices (MDR) has replaced the dated Medical Device Directive 93/42/EEC (MDD)…

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Newsletter

Regulatory Intelligence of Cosmetics Apr – Jun…

Regulatory Intelligence of Cosmetics for April through June of 2023.

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Whitepaper

Safety Assessment of E-Cigarettes in the EU

This whitepaper outlines safety requirements and key considerations in exposure assessments, hazard identification and risk assessments for e-cigarettes…

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Whitepaper

Safety Assessment of E-Cigarettes in the US

This whitepaper outlines safety and risk assessments as well as literature monitoring for e-cigarettes in the US.

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