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

  • Rethinking Early-Phase Outsourcing

    The CDMOs that bridge the fulfilment gap and truly become partners are likely the best choice for biotechs and pharma looking to develop their early-stage asset. While most CDMOs are well-versed in providing services with regular communication, sharing strategic objectives with clients, and ultimately providing the final material, it’s the “above and beyond” CDMOs that provide the real added value. read more

  • The Importance of a Hybrid Testing Approach for Safety Assessments in the NAM-Enabled Era

    For decades, in vivo models have been the standard in preclinical testing before a drug moves to first-in-human (FIH) trials. But a recent evolution in regulatory expectations has accelerated a steady shift away from in vivo testing, in favor of New Approach Methodologies (NAMs). read more