Regulatory Articles. App Notes, Case Studies. & White Papers

  1. Digital Transformation In Regulatory: Achieving Excellence Virtually 1/24/2022

    As the industry looks forward, key decisionmakers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.

  2. Addressing Development And Manufacturing Upheaval 1/24/2022

    Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future with uncertainty and disruption.

  3. Demonstrating Control Over The Manufacturing Process: QbD Studies 1/24/2022

    Understand the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.

  4. Pinpoint Manufacturing Steps That Require Tighter Control 1/24/2022

    With a complete picture of the parameters that control each step during manufacturing, chemists can monitor and control individual reactions to optimize the overall production process.

  5. Route Development: Designing Synthesis For GMP Production 1/24/2022

    The successful transition from initial synthesis of an API to a kilogram-scale route requires expert analysis and design, and a balance of economic, regulatory, and time constraints.

  6. Rapid Characterization Of Impurities 1/24/2022

    Understand how to manage impurities in drug development with swift isolation, synthesis, and analysis. A client discovered an impurity during ongoing stability studies that exceeded ICH guidelines.

  7. Qualified Reference Standards: Setting The Standard For Product Quality 1/24/2022

    Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity.

  8. Peptide Synthesis: Delivering Cost-Effective Strategies 1/24/2022

    For peptide APIs, using a liquid phase peptide synthesis (LPPS) approach offers a cost-effective process for large-scale manufacture by eliminating the need for specialized equipment and excess raw materials.

  9. Mitigating Hidden Risks: Extractables And Leachables 1/24/2022

    Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

  10. Method Optimization: Assay Development Following Compendial Methods 1/20/2022

    There was a short time frame of only 7 weeks to complete assay optimization and conduct pre-validation studies within the confines of USP<621>.