Navigating European Market Access & Reimbursement Strategy for Medical Devices and the Impact of HTAR

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Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe

Background Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical...

final fda guidance ich m13A requirements

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FDA Releases Final ICH M13A Guidance Document

On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. This guideline provides...

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Checklist for Building a Successful Risk Evaluation and Mitigation Strategy (REMS) Program

What is REMS? A Risk Evaluation and Mitigation Strategy (REMS) is a critical component of modern pharmaceutical regulation, designed to ensure that medications with serious safety risks are used...

Meet the Expert: Andrew Bright

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Meet the Expert: Andrew Bright

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

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Act Now! Navigating the Windsor Framework in the UK

A New Era for Pharmaceutical Development and Licensing in the UK The Windsor Framework, set to be implemented from January 1, 2025, marks a significant shift in the regulatory landscape for...

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Navigating the Nordic Pharmaceutical Landscape: Key Considerations for a Successful Launch

The Nordic region, renowned for its world-class healthcare, presents unique opportunities and challenges for pharmaceutical companies. Understanding the Nordic pharmaceutical landscape is crucial for...

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How to Create Successful Pricing and Reimbursement of your Pharmaceutical Product in the Nordics

Our Nordic region features world-class healthcare. Understanding the Nordic healthcare and market access landscape is crucial for successful pricing and reimbursement of your pharmaceutical product....

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PMA Post-Approval Study Considerations

In the US, post-market clinical studies are not required of every medical device manufacturer. However, the Food and Drug Administration (FDA) does have the authority to order post-market...

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Leveraging Offshore Excellence: Enhancing Medical Information Services Through Contact Centers in India & the Philippines

As the pharmaceutical landscape in the Japan and Asia-Pacific (JAPAC) region continues to evolve, the demand for efficient, high-quality medical information (MI) services has never been greater. Our...

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The Care and Feeding of FDA PMAs: Mastering Premarket Approval

Congratulations, FDA has approved your PMA! Now what? Securing a Premarket Approval (PMA) from the FDA is a significant achievement for any medical device manufacturer—a validation of your product's...

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