Clinical Supply Regulatory Articles

1. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

   ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

2. The Small Biotech's Checklist For FIH Trials 8/27/2024

   Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.

3. Good Distribution Practice Is Evolving — Here's How 5/15/2025

   Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.

4. Challenges In Manufacturing TIL For Clinical Trials 3/6/2025

   Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.

5. 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.

6. New Initiative Seeks To Back Up ICH's Harmonization Mission 5/3/2024

   An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.

7. New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability 6/28/2024

   A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.

8. Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs 11/20/2023

   Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.

9. The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups 1/19/2023

   How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

10. What Sponsors Must Know About Digital Systems And AI Compliance 7/17/2025

    Consultant Jessica Cordes provides an update on proposed changes to GMP guidance that affect trial conduct, including documentation, computerized systems, and the use of AI.