Clinical Supply Regulatory Articles

  1. U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact 2/18/2026

    Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.

  2. Managing Risk And Resilience In Clinical Trial Supply And Operations 2/12/2026

    Clinical leaders are shifting from reactive fixes to deliberate governance and early decision-making to sustain trial continuity under persistent operational uncertainty.

  3. FDA Staffing Constraints And Operational Risk In Clinical Supply 2/11/2026

    FDA staffing shortages and supply pressures are reshaping clinical trials, requiring closer coordination across regulatory, manufacturing, and operations.

  4. Tariffs Threaten Clinical Trial Supply Chains: Preparing For Volatility 2/10/2026

    Tariffs and FDA staffing gaps are quietly reshaping clinical trial supply chains. From comparators to customs delays, these forces are creating real risk for timelines, budgets, and patients.

  5. Navigating Brazil's Medical Device Clinical Trial Import Process 1/27/2026

    When medtech sponsors plan clinical trials in Brazil, many overlook a critical bottleneck that can delay trial launches by months: the process of importing clinical trial materials.

  6. Managing Supply Chain Risk In Scale-Up And Multisite Trials 1/23/2026

    Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.

  7. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

    This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

  8. Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development 11/17/2025

    The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

  9. On The Potency Assurance Journey, Travelers Need A Road Map 11/13/2025

    When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.

  10. Global Implications Of Zero Tariffs On Indian Pharma Exports To China 11/5/2025

    Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.