Demystifying eCTD 4.0: What You Need to Know
Electronic Common Technical Document (eCTD) submissions have transformed sponsor companies'...
Mastering a Global Approach to Medical Writing
Medical writing plays an essential role in clinical development and regulatory approval. As...
A Sponsor Checklist for Better Patient-Centric Trial Decisions
In today’s increasingly complex clinical research environment, sponsors must strike a careful...
Planning Your IND: When and Why to Engage the FDA
Many sponsors underestimate how much support the Food and Drug Administration (FDA) can offer...
Reflections from ASCO 2025
Clinical Impact, Technology Innovation, and Emerging Advances in Cell and Vaccine-Based Oncology
Project Optimus Explained: Why the FDA is Shifting Away from Maximum Tolerated Dose in Oncology
Historically, oncology drug development followed a straightforward principle: identify the highest...
Monthly FDA Guidance and Regulatory News Review - May 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Staying Ahead of Regulatory Change: CMC Strategies for Cell and Gene Therapy Development
The regulatory landscape for cell and gene therapies (CGTs) is shifting fast. From increased...
Marketing Application Publishing Best Practices
Effectively managing the publishing of documents required for a marketing application submission...
Multi-Regional Clinical Trials: Key Recommendations for a Global Clinical Development Program
The FDA recently released a draft guidance on the use of multi-regional clinical trials (MRCTs) in...