Regulatory Submissions

Since its incorporation, Veristat has been instrumental in the production of over 14 successful and pending NDA/CTD and BLA filings, including the design, statistical production, and writing of clinical study reports, integrated summaries, and other summary documents. This experience is specifically within the context of Veristat itself. Veristat employees individually have additional NDA and BLA experience from previous positions in the pharmaceutical industry.

FDA Representation

In his role as a strategic statistical consultant, Dr. John Balser has represented clients at over 20 meetings at the FDA since 2000. In addition, Veristat personnel have prepared FDA briefing documents, responses to FDA questions, and slides for presentation at Drug Advisory Committee meetings. Veristat personnel also have attended Drug Advisory Committee meetings to assist clients with real-time data presentation in response to committee member questions.