Achieve Regulatory Excellence and Accelerate Your Clinical Trials with Veristat

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.