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Marketing Applications Approval Record

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 ...

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Fact Sheet

Overcoming Data Analysis Hurdles

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

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Fact Sheet

Key Tips for Marketing Application Preparation

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

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Fact Sheet

Medical Writing Success Strategies

Careful planning and an optimized timeline can shorten the time required to produce effective, consistent marketing application documents.

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Fact Sheet

Managing the Operational Complexities of Marketing Application Preparation

Learn how to plan and manage the timeline and operational approaches for marketing application planning, mid-stream adaptation, and final submission.

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Case Study

First Gene Therapy Approved in Europe

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 ...

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Webinar Presentation

A Webinar Presentation: Expanding your Clinical Trial into the US

Get the webinar presentation  on how, why and when to expand your clinical trial program into the US, including differences between IND and CTA

 

 

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Webinar Video Replay

A Webinar Replay | Expanding your Clinical Trial into the US

Watch the on-demand webinar  on how, why and when to expand your clinical trial program into the US, including differences between IND and CTA

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Newsletter

The Rapid Pace of Regulatory Change

Read our June 2021 of edition of our Newsletter, Voyager, which provides insights on the value a Veristat partnership delivers to overcome the regulatory hurdles that arise during ...

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