Regulatory Approvals

Preparing Regulatory Marketing Applications to Their Successful Conclusions Is Our Focus

Veristat delivers integrated marketing application (NDA, BLA, MAA, NDS, jNDA, etc) preparation expertise with a track record of success and achievement of seemingly impossible deadlines.  Our success lies in our ability to navigate operationally complex submissions, overcome data analysis challenges, and streamline the medical writing process with an integrated team focused on creativity, flexibility, and quality.

Helping You Achieve Regulatory
Approval Success 

We provide strategic consulting, biostatistical and programming support, CDISC compliant data standardization, and medical writing services to help you prepare and defend your regulatory submissions. We advise on overall regulatory submission strategy and assist with developing the overall marketing application project plan and timelines.   We know how to work collaboratively with other third parties to bring all aspects of a submission together. And, our regulatory publishing team is poised to submit your marketing applications to FDA. 

Marketing Application Preparation and Approval Success

Fundamentals of the Marketing Application

Regulatory Submission Expertise_PlanningThroughPost ApprovalOur teams are highly skilled and experienced in supporting the development of the following documents and analyses:

  • Phase III Pivotal Clinical Study Reports
  • Modules 2.3 and 2.4
  • Clinical Overview – Module 2.5
  • Summary of Clinical Efficacy (SCE) – Module 2.7.3
  • Summary of Clinical Safety (SCS) – Module 2.7.4
  • Module 3 Gap Analysis
  • Integrated Summary of Safety (ISS) – Module 5
  • Integrated Summary of Efficacy (ISE) – Module 5
  • Regulatory Analysis of Overall Application
  • SDTM Compliant Dataset
  • ADaM Compliant Datasets
  • ISS/ISE ADaM Dataset Creation
  • Regulatory Briefing documents
  • Written and Rapid Responses to Regulatory Authority Questions
  • Creation of Slides for Regulatory Presentations
  • 4-Month Safety Updates
  • Annual Reports

Our Expertise In Regulatory Approval Applications

Regulatory CRO Experts at FDA Meeting Support

Veristat has been instrumental in the preparation of over 110 marketing applications that have led to more than 60 approvals so far. Our teams have represented pharmaceutical and biotechnology companies in direct regulatory interaction with the US FDA, Health Canada, European Medicines Agency (EMA), Korea FDA and Japan FDA.  We have participated in on-site meetings at regulatory agencies and acted as statistical and clinical experts for advisory panel meetings, including acting as the client statistical representative for many of these panels.

Our senior consultants have over twenty-five years of experience guiding companies through the regulatory submission process. We bring together expert regulatory consultants, biostatisticians, medical writers, data standards professionals and statistical programmers who work collaboratively to help our clients prepare their regulatory dossiers for submission and continue to support them throughout the agency review process.                                                     

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