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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?

Home > Services > Marketing Applications

Successfully Navigate the Preparation Process

Home > Services > Marketing Applications

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:

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Pivotal Clinical Study Reports
All Modules of the eCTD
Regulatory Analysis of the Marketing Application
SDTM Compliant Datasets
ADaM Compliant Datasets
ISS/ISE ADaM Dataset Creation
Regulatory Briefing documents

Agency Meeting Attendance and Support
Responses to Regulatory Authority Questions
Creation of Regulatory Presentations
Annual Reports and Safety Updates
Pharmacovigilance and Risk Management Plans
Publishing to Regulatory Agencies

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Accelerate Marketing Application Preparation

Position Your Marketing Application for Regulatory Approval

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Connect with a Marketing Applications Expert Today.

Successfully Navigate the Preparation Process

Marketing Application Preparation: End-to-End Solution

Start One Year Prior to Submission Date

Obtain Regulatory Approval for your Marketing Application

Insight Brief: Successful Preparation Strategies for NDA/MAA Marketing Applications

Case Study: Advancing to Your Next Milestone – Global Regulatory Excellence Throughout the Entire Clinical Development Lifecycle

Case Study: US & EU Approval for an Ultra-Rare Hematologic Malignancy

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