Weighing the Suitability of a Functional Service Provider (FSP) Model for Clinical Trials
Clinical and regulatory teams face increased pressure to drive uninterrupted progress across the...
On-Demand Webinar: Decentralized Trial Solutions for Complex Clinical Trials
Decentralized clinical trials (DCTs) are becoming increasingly popular to optimize patient...
On-Demand Webinar: Orphan Drug Designation - The Considerations, The Rewards, and How They Differ Between The US and Europe
Did you know approximately 1 in 10 Americans are affected by a rare disease or condition according...
Rolling Review mechanisms and CMAs (Conditional Marketing Authorisations) have made it possible to speed up the approval of treatments against Covid-19
GENESIS BIOMED recently interviewed Xavier Luria, former Head of Safety and Efficacy of Medicines...
Shortening Development and Approval Timelines for Novel Medicinal Products
The FDA and EMA offer expedited regulatory approval pathways to accelerate time-to-market for novel...
Autologous and Allogeneic Cell Therapies: Benefits, Challenges, and Future Prospects
Cell and gene therapies (CGT) are at the frontline of clinical research and offer the potential to...
Regulatory Guidance Monthly Review - September 2022
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Regulatory Publishing Expertise for an Efficient NDA Submission Process
Veristat supported a commercial stage biopharmaceutical company in NDA submission, bringing...
Regulatory Guidance Monthly Review - August 2022
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Planning the Way Forward for a New Tumor Evaluation Modality
RECIST (Response Evaluation Criteria in Solid Tumors) guidelines were introduced over twenty years...