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...
Dedicated Regulatory Project Management
Drug developers hire regulatory consultants and CROs to help navigate the complex regulatory agency...
Regulatory Guidance Monthly Review - March 2023
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Bold Thinking that Delivers Results for RNA Therapies
Current advances in RNA-based therapies hold substantial promise in treating and preventing many...
CMC Pitfalls: From Benchtop to IND
Successfully transitioning from academic or bench-top production to manufacture clinical-grade...