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Marketing Applications
Services
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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Marketing Applications Prepared to Date
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Let's Talk.
Contact Veristat Today!We know there are always unknown challenges when bringing a novel therapeutics to market, so we’ve assembled an extraordinary team of scientific minded experts who have mastered the complexities of therapeutic development enabling sponsors to succeed in extending and saving lives.
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Marketing Applications
Successfully Navigate the Preparation Process
Marketing Application Preparation: End-to-End Solution
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Develop timeline
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Analyze and standardize trial data
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Write all modules and dossiers
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e-Publishing
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Support post-submission activities
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Develop PV and Risk Mitigation Plans
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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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Marketing Applications
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Pivotal Clinical Study Reports
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All Modules of the eCTD
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Regulatory Analysis of the Marketing Application
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SDTM Compliant Datasets
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ADaM Compliant Datasets
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ISS/ISE ADaM Dataset Creation
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Regulatory Briefing documents
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Agency Meeting Attendance and Support
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Responses to Regulatory Authority Questions
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Creation of Regulatory Presentations
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Annual Reports and Safety Updates
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Pharmacovigilance and Risk Management Plans
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Publishing to Regulatory Agencies
Obtain Regulatory Approval for your Marketing Application
Learn More with These Resources
Fact Sheet
Marketing Application Fact Sheet
Fact Sheet
Neurology Psychiatry Fact Sheet