Regulatory Submission Support

We understand the complexities of the regulatory submission process- we work on them daily- and we know what it takes to be successful at the FDA and abroad. We also know that to effectively support a submission, you must have a focused and dedicated team that is accessible, flexible and multifaceted. Veristat’s highly experienced and skilled cross-functional team works intimately with you throughout the regulatory submission process so together we can bring new medical products to those who need them.

How We Help

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 submission strategy and assist with developing the overall project plan and timelines.   We know how to work collaboratively with other third parties to bring all aspects of a submission together.

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Our Regulatory Submission Services

Our teams are highly skilled and experienced in supporting the development of the following documents and analyses:

  • Phase III Pivotal Clinical Study Reports
  • Clinical Overview – Module 2.5
  • Summary of Clinical Efficacy (SCE) – Module 2.7.3
  • Summary of Clinical Safety (SCS) – Module 2.7.4
  • Integrated Summary of Safety (ISS) – Module 5
  • Integrated Summary of Efficacy (ISE) – Module 5
  • SDTM Compliant Datasets
  • 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 Submission Work

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Veristat has been instrumental in the production of over 50 regulatory submissions.     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 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 biostatisticians, medical writers, data standards professionals and statistical programmers who work collaboratively to help our clients prepare their submissions and to support them throughout the review process.

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