The Influence of MDR’s Article 117 in the Marketing of Combination Products
The European Union Medical Device Regulation’s (MDR) Article 117 brings improved patient safety...
Migration of Data Between EDCs
Factors such as ongoing industry consolidation, continual regulatory change, rapid technology...
Successful Full-Service, Randomized Pancreatic Cancer Phase II Trial
Learn how Veristat’s multidisciplinary team was able to work with the sponsor to solve challenges...
How does Real-World Evidence Impact Medicinal Product Development in Europe?
Explore the growing role of Real-World Evidence (RWE) in the regulatory decision-making process...
Regulatory Guidance Monthly Review - May 2023
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
The Rise of Decentralized Clinical Trials: Transforming Research Through Technology and Patient-Centricity
Learn how decentralized clinical trials (DCTs) are reshaping the clinical research landscape....
Apples to Apples: Playing the Comparability Game in Biotherapeutics Development
Comparability studies are a significant issue for those working in biotherapeutics development, as...
Understanding FDA's Project Optimus
Project Optimus is an initiative from the FDA Oncology Center of Excellence led by Drs. Mirat Shah...
Regulatory Guidance Monthly Review - April 2023
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Regulatory Considerations for Biosimilars Development in the U.S.
The development of biosimilar products in the U.S. has progressed since the regulatory pathway was...