Pharmaceutical Destruction and Clinical Supply Chain Solutions

Executing Phase I through Phase III clinical trials involves severe operational hazards. Failing to perform tablet-level unit counts or complete drug accountability exposes sponsors to severe audit findings.

Our tailored clinical supply operations mitigate these risks:

• Eliminating Drug Waste: Conventional bulk packaging leads to high drug disposal volumes and wasted capital. Our Just-In-Time (JIT) packaging models prepare patient-specific kits on demand, saving vital API reserves.
• Resolving Expiration Updates: Stability extensions often require immediate label modifications. We perform precise over-labeling, de-labeling, and expiration date extension labeling to keep active clinical sites fully compliant.
• Guaranteeing 100% Reverse Accountability: Federal regulations require complete tracking for every experimental medicinal item. We handle full reverse logistics, disassembling individual clinical kits and performing tablet-level counting before executing final pharmaceutical destruction through certified, licensed facilities.

Our packaging, labeling, and logistical capabilities accommodate diverse trial designs, complex dosage forms, and strict regulatory standards. We organize our primary and secondary services into three focused operational blocks designed to secure product integrity and streamline trial execution.

1. Advanced Packaging & Precision Labeling

We perform secondary clinical packaging alongside specialized labeling services. Our expertise covers sachet/pouch labeling, over-labeling, primary de-labeling, expiration date extension labeling, and child-resistant packaging assembly tailored to your protocol.

2. On-Demand Just-In-Time (JIT) Kitting

Our JIT patient-specific packaging delivers custom clinical supplies per patient, per study visit, and per site. This approach grants sponsors maximum control over distribution schedules, reduces overall study costs, and conserves scarce drug products.

3. Integrated Logistics & Certified Destruction

We manage domestic and international temperature-controlled shipping, same-day distribution requests, and full returns reconciliation. Upon trial closeout, our team completes tablet-level unit counts, generates complete accountability documentation, and oversees final pharmaceutical destruction at licensed facilities.

Maintaining product stability requires precise, monitored environmental controls across the entire life cycle of your study. Patwell operates a 20,000-square-foot cGMP facility in Coatesville, Pennsylvania. The infrastructure includes 24-hour monitoring, full emergency generator backup power, five secondary packaging suites, and one limited primary packaging room with a laminar flow hood.