Latest Articles

  • Post-Approval Change Management

    Achieving global approval for a single change may take three to five years, but inefficient lifecycle change management rarely registers as a crisis. read more

  • The Operational Foundations That Characterize Regulatory Leaders

    Holding individuals and teams explicitly accountable for data accuracy and quality might seem straightforward, but it is difficult to sustain in practice. 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

  • Patient-Centric Drug Delivery

    Across modalities and markets, patient-centric drug delivery is converging on three themes: self-administration at home, integration of drug delivery device platforms earlier in clinical trials, and alignment of formulations with device and human factors requirements. read more