Featured Insights

1. Streamlining European Expansion With Integrated PV, Regulatory, And Commercial Expertise 4/17/2026

   See how a single-provider model integrated pharmacovigilance with regulatory and commercialization support to support a scalable, audit-ready system that strengthened compliance and freed internal resources for growth.

2. Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ 1/6/2025

   The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.

3. A Thoughtful Copay Program Design That Increased Patient Engagement 11/26/2024

   Learn how a partnership with a pharmaceutical company to redesign patient support materials resulted in increased patient engagement and copay program utilization.

4. Understanding The EU Regulatory Landscape For Cell And Gene Therapies 4/9/2026

   EU approval for cell and gene therapies isn't just a different process, it's a different playbook. Here's what US manufacturers need to know before they engage.

5. Partnering With Health Systems: Essential Tips For CGT Commercialization 12/5/2025

   Successful cell and gene therapy commercialization requires early, detailed manufacturer collaboration with health systems to ensure scalable operations and seamless patient access beyond the clinical trial.

6. Specialist PV Support Transforms Safety For Orphan Medicinal Products 4/17/2026

   Learn how a UK-based company developing two orphan-designated, centrally authorized therapies successfully navigated operational challenges after transitioning from a prior provider.

7. Transforming PSP Enrollment To Enhance User Experiences And Optimize Workflows 2/18/2026

   Lengthy enrollment calls burden patients and PSP teams alike. See how a digital-first intake approach cut onboarding time and improved outcomes for everyone involved.

8. Digitized Solutions To Increase Visibility And Streamline Communication Between A PSP And Manufacturer 2/18/2026

   When email-based escalation management creates compliance and visibility gaps, a centralized digital solution helps manufacturer and PSP teams act faster and with greater accountability.

9. Unraveling The Complexity Of Cell Therapy: Advancements And Challenges 11/26/2024

   Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.

10. Addressing A Critical Drug Shortage 4/20/2026

    A critical drug shortage demanded regulatory action, importation support, and patient program readiness. See how integrated QA, 3PL, and PSP capabilities delivered operational readiness in three months.