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Clinical Research Solutions

European Pharma Regulations: 2024 Review and 2025 Trends to Watch

Gaining a Competitive Edge: 2024's European Pharma Regulatory Review & Trends to Look for in 2025 and Beyond As the pharmaceutical landscape in Europe evolves rapidly, regulatory frameworks are...

Clinical Research Solutions

Excelling in the JAPAC Medical Information Landscape: Key Considerations and Insights

As a rapidly expanding market, the Japan and Asia-Pacific (JAPAC) region presents a unique and complex landscape for those who are looking to establish a medical information (MI) function. Having a...

FDA Recommendations for Confirming an Ames Positive Finding

Clinical Research Solutions

Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding

On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...

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

Clinical Research Solutions

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

Clinical Research Solutions

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...

Clinical Research Solutions

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

Clinical Research Solutions

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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Clinical Research Solutions

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...

Clinical Research Solutions

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...

Clinical Research Solutions

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....

Clinical Research Solutions

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...

Clinical Research Solutions

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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Clinical Research Solutions

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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Clinical Research Solutions

Navigating EU GMP Compliance: A Consultant's Guide to Smooth Sailing

Hello, fellow pharma enthusiasts! In the fast-paced world of pharmaceuticals, ensuring Good Manufacturing Practice (GMP) compliance is essential to maintaining product quality and safety. The...

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Clinical Research Solutions

Navigating the Regulatory Maze: Clinical Data for Medical Device Approval

In the world of medical devices, particularly those categorized as moderate to high-risk, clinical data is a critical component of the regulatory approval process. This data, presented to regulatory...

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Clinical Research Solutions

How a Strong Regulatory Strategy Supports Your Product’s Success

One of the big questions pharmaceutical, biotech and medical device companies often ask, is: “When is the optimal time to seek strategic regulatory consulting assistance?”. Traditionally, the need...