Latest Articles

  • Safely Scaling Highly Potent API manufacturing

    Ever more drug developers are searching for CDMOs with contamination-limiting capabilities. But how can they know which have these high-potency credentials? read more

  • 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

  • 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