Clinical Supply Regulatory Articles

  1. Choosing The Right Logistics Team For Complex Clinical Trials 3/3/2026

    Global trials demand more than shipping. Learn how IoR, EoR, cold chain control, and proactive logistics teams protect timelines, compliance, and patients.

  2. Navigating FDA Inspections: Practical Steps For Clinical Supply Leaders, Part 2 2/25/2026

    FDA inspections are evolving. Equip your clinical supply team to manage on-site and remote audits with confidence and turn findings into stronger systems.

  3. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

  4. FDA Publishes Final Guidance On Reporting Listed Drug Amounts 4/10/2024

    Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.

  5. Making Cancer Vaccines Is Complex; New Platform Guidance Could Help 7/3/2024

    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

  6. 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.

  7. 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.

  8. Solving Pharmacy And Clinical Supply Challenges In Decentralized Trials 4/8/2026

    Decentralized trials promise better patient access but create major supply risks. From cold chain failures to regulatory hurdles, here is what sponsors must solve now.

  9. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

    Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

  10. New Group Wants 'Phase-Appropriate' Thinking To Retire 9/4/2025

    Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.