Veristat has been instrumental in the preparation of over 140 marketing applications that have led to 75 approvals so far. Our teams have represented pharmaceutical and biotechnology companies in direct regulatory interaction with the US FDA, Health Canada, European Medicines Agency (EMA), Korea FDA, and Japan FDA.  We have participated in on-site meetings at regulatory agencies and acted as statistical and clinical experts for advisory panel meetings, including acting as the client statistical representative for many of these panels.

Our senior consultants have over twenty-five years of experience guiding companies through the regulatory submission process. We bring together expert regulatory consultants, biostatisticians, medical writers, data standards professionals, and statistical programmers who work collaboratively to help our clients prepare their regulatory dossiers for submission and continue to support them throughout the agency review process.