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

  • 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

  • Horizon Lines: A Quarterly Review of NDAs – January-March, 2026

    The NDAs approved during the first quarter of 2026 have been divided into the dosage forms Injection, Tablets, Capsules, Oral solution, Gas, and other. read more

  • From Data to Tissue

    The national-security regulatory landscape now layers a geopolitical framework onto the data flows, sample logistics, and vendor relationships that make modern clinical research possible. This architecture will not simplify. The DSP’s country-of-concern list may expand, the BIOSECURE Act’s designated-entities list will likely grow, and state legislatures continue adding requirements. read more