Regulatory Solutions

  1. A More Intuitive IRB Submission Experience 7/21/2026

    Gain insight into a more intuitive IRB submission experience that can help reduce friction, improve transparency, and support today’s virtual research workflows.

  2. Your IRB, Simplified: Fast, Friendly, And Focused 7/21/2026

    IRB approval does not have to be defined by delays or confusion. Learn how expert guidance, regulatory support, and modern technology can help research teams move forward with greater efficiency.

  3. Independent IRB Approval, Simplified 7/21/2026

    Partner with Univo IRB for the participant-centered service and forward-thinking technology you need to navigate a changing industry and get independent IRB approval, faster.

  4. Accelerate Drug Development With Innovative 360˚ CDMO And CRO Solutions 6/9/2026

    Accelerator™ Drug Development provides a strategic, end-to-end partnership model that helps sponsors optimize resources, overcome development challenges, and advance promising therapies.

  5. ICH E6(R3) Is Here: How Should You Handle It? 5/27/2026

    Prepare for ICH E6(R3) with integrated oversight, audit-ready data, and streamlined trial operations designed to reduce burden, accelerate timelines, and support compliance.

  6. Support For Efficient FDA Interactions 5/27/2026

    In today’s regulatory climate, ongoing discussion about FDA workload, funding constraints, and shifting review priorities have sparked anxiety across the biopharma industry — especially for sponsors preparing for key submissions like INDs or NDAs. At Veristat, our most recent interactions reflect continued responsiveness and constructive engagement from FDA.

  7. Data-Driven Paths To Rare/Ultra-Rare Disease Therapy Approval 5/22/2026

    Explore how integrated regulatory, statistical, and operational expertise can be applied to help sponsors navigate complex development pathways and accelerate global approvals.

  8. Human Abuse Potential: Selecting A Positive Control 5/8/2026

    Choosing an effective positive control in HAP studies is critical but not always straightforward. Learn how to justify comparator and dose selection.

  9. Human Abuse Potential: CSS Interactions 5/8/2026

    Learn how, by embedding FDA engagement into the development process, sponsors can strengthen their abuse potential assessment and support smoother regulatory review.

  10. Human Abuse Potential: Subjective Ratings 5/5/2026

    Accurate subjective ratings are central to Human Abuse Potential studies. Learn how Visual Analog Scales are administered, what influences responses, and why data collection practices are essential.