Home > Blog > Achieve regulatory excellence and accelerate your clinical trials with veristat

1 min read

Achieve Regulatory Excellence and Accelerate Your Clinical Trials with Veristat

Strategic Consulting

Learn how Veristat’s multidisciplinary team helped sponsors navigate the complexities of global regulatory submissions, achieving early and successful outcomes.

In one case, a clinical-stage biopharmaceutical company approached us for an IND submission for an antibody therapy targeting cancer. Our team adapted to staffing challenges on the sponsor’s end, executing a flawless submission that led to FDA clearance ahead of schedule.

In another instance, we supported a biopharmaceutical company with multiregional submissions for a novel therapy targeting a rare genetic metabolic disease. By optimizing resources, Veristat experts helped secure orphan drug designations and priority reviews with both EMA and FDA.

Additionally, a small biotech developing a novel autoimmune therapy sought our expertise for a three-tiered marketing submission to FDA, MHRA, and EMA. Despite competitive pressures, our strategic approach ensured timely submissions and ongoing support.

Discover how Veristat can help you achieve regulatory success by downloading our case study today.

DOWNLOAD NOW

 

1 min read

ASH Annual Meeting and Exposition

Oct 22, 2025  Veristat Events

Meet Veristat at ASH Meeting and Exposition December 6-9, 2025

Veristat is excited to attend the ASH Annual Meeting and...

2 min read

2nd Annual Clinical Outsourcing Group CRO Summit

Oct 17, 2025  Veristat Events

Meet Veristat at 2nd Annual Clinical Outsourcing Group CRO Summit December 2-3, 2025

Veristat is proud to participate...