Compliance assistance with NDA/CTD and BLA filings
Regulatory Submissions
Since its incorporation, Veristat has been instrumental in the production of numerous 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. Veristat employees individually have additional NDA and BLA experience from previous positions in the pharmaceutical industry.
Veristat's strategic statistical consultants have represented clients at numerous meetings at the FDA since 2000. Additionally, Veristat personnel have prepared FDA briefing documents, responses to FDA questions, and slides for presentation to the FDA. With our experience, we guide our clients through the regulatory process, from regulatory strategy to client representation at FDA meetings.