Regulatory Sciences
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On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...
Regulatory Sciences
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...
Regulatory Sciences
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...
Medical Information
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...
Quality & Compliance
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...
Regulatory Sciences
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...
Pharmacovigilance
EU Clinical Trials Regulation: Time Is Running Out, Are You Ready?
On January 31, 2022, the EU Clinical Trials Regulation 536/2014 (CTR) came into force with a transition period of three years. Now, as that transition period comes to a close, the process and need...
Regulatory Sciences
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...
Regulatory Sciences
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...