Latest Articles

  • An Interview With Franco Negron

    Simtra’s capability to support high-volume injectables and lower-volume modalities provides balanced expertise across the sterile injectables landscape. read more

  • Flexibility as a Core IND Strategy

    With the increasing complexities of current IND programs, it is critical to work with regulatory agencies to seek input early in the process. read more

  • Beyond Case Management

    In large pharma, a staggering 40 to 50 percent of expert pharmacovigilance time is still consumed by tasks far removed from active, scientific PV - such as the mechanics of scheduling reports, tracking down contributors, and managing documents. read more

  • The Evolving Regulatory Landscape for Cell and Gene Therapies

    The regulatory landscape for CGTs is moving towards more explicit, risk-based assessment of intended editing outcomes, off-target activity, and genomic integrity. This evolution reflects both the promise of new editing technologies and the need to understand their potential consequences in clinically relevant biological settings. read more