Importer of Record in Pharma Logistics: Why Global Clinical Supplies Get Delayed
Navigating international borders requires clear, compliant legal ownership over investigational drug shipments. This comprehensive guide details why clinical trials face customs clearance bottlenecks. Learn how the proper assignment of an importer of record protects sensitive therapies, simplifies clearance, and keeps global clinical development programs moving on schedule.
Cleaning Validation Acceptance Criteria: How CDMOs Set Limits for Shared Facilities
Managing multi-product manufacturing lines requires scientific, risk-based contamination controls to preserve patient safety. This technical guide explores how contract manufacturers calculate cleaning validation acceptance criteria across shared lines. Learn to establish active ingredient residue limits, evaluate toxicological risks, and verify cross-contamination thresholds successfully.
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Importer of Record in Pharma Logistics: Why Global Clinical Supplies Get Delayed
July 7, 2026EU vs U.S. CDMO Inspections Differences: What Global Sponsors Must Prepare Before Tech Transfer
July 4, 2026India vs China CDMO Outsourcing: Cost, Quality, and Regulatory Trade-Offs for Sponsors
July 3, 2026Biologics
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Evotec and Sandoz Explore $300M Biologics Unit Sale in Toulouse: CDMO Capacity Shifts
Evotec has entered a non-binding agreement with Sandoz to explore the $300M sale of its Toulouse biologics facility, signaling shifts in CDMO capacity and outsourcing dynamics.
Read Full Story- Biotech – June 8, 2026 The Biggest Downstream Purification Bottlenecks in Biologics Manufacturing
- Pharmaceuticals – July 9, 2026 Controlled-Release Tablet Scale-Up: Common Formulation Problems CDMOs Must Solve
- Supply Chain and Logistics – July 7, 2026 Importer of Record in Pharma Logistics: Why Global Clinical Supplies Get Delayed
Latest Expert Post
Direct-to-Patient Shipments: What I Said in 2021 — and What We See in 2026
Developing biosimilars involves navigating complex manufacturing and regulatory challenges that go far beyond traditional generics. This guide explores key hurdles—from analytical characterization to large-scale production—and highlights how strategic CDMO partnerships help ensure similarity, scalability, and commercial success.
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Cold Chain Logistics in Biologics Manufacturing: Preventing Temperature Excursions
Maintaining the integrity of temperature-sensitive therapies is the greatest challenge in modern medicine. This guide explores how cold chain logistics biologics manufacturing protocols prevent temperature excursions, utilize real-time monitoring, and ensure regulatory compliance. Learn about specialized packaging, risk mitigation strategies, and the role of CDMOs in securing the global supply chain.
Adventitious Agent Testing in Biologics: Building a CDMO Testing Strategy That Regulators Accept
Protecting biologics from viral, bacterial, and fungal contaminants is a regulatory mandate. This 2,500-word guide details Adventitious Agent Testing strategies at CDMOs. Explore in vitro and in vivo assays, Next-Generation Sequencing (NGS) trends, and how to structure your testing program to ensure safety and clinical success.
CDMO world AI Summer Series· Launches June 15
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ClinicalTrials.gov- Essentials for Academic Medical Centers
APPOS Austin 2026
CDMOworld Weekly Live Broadcast
15-Minute Industry Wrap-Up
A fast, focused live video broadcast covering the most important moves across the CDMO landscape — deals, capacity, regulatory shifts, and the people behind them.