Accelerate Marketing Application Preparation

Position Your Marketing Application for Regulatory Approval

Navigating the global regulatory landscape in today’s world is increasingly long and complex. Sponsors cannot afford mistakes or delays when it comes to preparing and submitting marketing applications - NDAs, BLAs, sNDAs, NDSs, MAAs, and jNDAs - to regulatory authorities around the world.

With a proven record of success, Veristat delivers end-to-end marketing application expertise and assists you through every step of the regulatory approval process. Our integrated team of submission experts provides regulatory consulting, biostatistical and programming support, CDISC-compliant data standardization, medical writing, and publishing services to help you confidently plan and execute your regulatory submissions.

Want to accelerate success and shorten your marketing application preparation timeline?

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Start One Year Prior to Submission Date

Veristat recommends that you begin your Marketing Application preparation and submission timeline at the start of your pivotal trial or at least one year prior to your target submission date. Our teams are highly skilled and experienced in supporting the development, writing and quality control of the following: