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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 clinical trial applications and marketing applications to health authorities.

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 provide 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.

Preparing a marketing application? Let's talk!

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Marketing Applications Prepared to Date

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Marketing Applications Approved Globally to Date

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Rare Disease Marketing Application Approvals in the past 5 years

Successfully Navigate the Preparation Process

 
Marketing Application Preparation: End-to-End Solution
  • Develop timeline
  • Analyze and standardize trial data
  • Write all modules and dossiers
  • e-Publishing
  • Support post-submission activities
  • Develop PV and Risk Mitigation Plans

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:

  • 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

Obtain Regulatory Approval for your Marketing Application 


Want to ensure a streamlined marketing application preparation and submission process?

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