Clinical Research Solutions
The pharmaceutical industry has shown a growing interest in single-arm trials due to their potential to expedite drug development. However, several challenges and concerns remain. The European...
Clinical Research Solutions
Congratulations! You have a lead candidate formulation for your new drug. You might be thinking to yourself, “okay, now what?” We all know the science and effort to get to this stage is significant....
Clinical Research Solutions
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
On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...
Clinical Research Solutions
Background Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical...
Clinical Research Solutions
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
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
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....