Veristat Case Studies

  1. Successful SwissMedic Marketing Authorization Application For An Oncology Therapy 6/4/2026

    See how strategic EU dossier adaptation and Swiss-specific regulatory expertise enabled a successful SwissMedic submission and accelerated market access for an oncology therapy.

  2. End-To-End Clinical, Biometrics, And Regulatory Support In Neurology 6/4/2026

    Discover how an integrated NDA strategy aligned data, vendors, and regulatory execution to achieve an on-time submission and approval without major FDA queries.

  3. Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration 5/27/2026

    Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.

  4. Relieving Pressure During Preparation Of A High-Volume sNDA 5/27/2026

    Managing a complex sNDA under pressure? See how one sponsor achieved an early FDA submission through coordinated publishing, regulatory strategy, and flawless execution.

  5. Supporting Global Approval Of A First-In-Class Gene Therapy For A Rare Genetic Disorder 5/27/2026

    Global approvals for a first-in-class gene therapy don’t happen by chance. See how adaptive oversight and inspection readiness kept a complex rare disease program moving forward.

  6. Targeted Indication Selection Using Adaptive Design 8/12/2025

    What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?

  7. Advancing Dose Escalation Strategies With Bayesian Modeling 8/12/2025

    A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.

  8. Building A High-Quality IND From Scratch With Strategic Gap Analysis 8/12/2025

    A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

  9. NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission 8/12/2025

    A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).

  10. Advancing Oncology Innovation With Adaptive Trial Designs 8/12/2025

    When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.