Veristat Library

Infographic

While a pre-IND Meeting with the FDA is optional, the Regulatory team at Veristat highly recommends that all
drug developers planning to submit an IND to the FDA have a pre-IND ...

Infographic

Suppose the goal of a development program is to initiate clinical trials within European member states, the United Kingdom, or North America. In
that case, strategic consideration to ...

Case Study

Veristat was brought in to create and manage a full development program for a gene therapy for a very rare inherited disorder. The work involved charting the course in unexplored waters ...

Published Article

While there is no ‘out-of-the-box’ roadmap for orphan drug development, through a toolkit of innovative solutions, we can address the unique aspects of clinical development in rare ...

Webinar Video Replay

Historically, cell and gene therapies have been used to cure rare and ultra-rare diseases. With new efficiencies on the horizon, what does this mean for the future of these therapies and ...

Webinar Presentation

Historically, cell and gene therapies have been used to cure rare and ultra-rare diseases. With new efficiencies on the horizon, what does this mean for the future of these therapies and ...

Infographic

Veristat is proud to have supported the preparation of 75 marketing applications (NDA, BLA, MAA, etc) that are now approved for patients. For these approved products, direct involvement ...

Fact Sheet

Learn how to strategically migrate and produce clinical trial data outputs in submission-ready format to reduce timelines without sacrificing data quality.

Fact Sheet

From our years of experience preparing marketing applications, Veristat has learned there are three key tips to planning.