GMP Storage

PBLI’s cGMP storage facility offers multiple conditions to accommodate your clinical trial supply needs.  We can handle small-scale Phase I studies to large Phase III studies.  Standard USP conditions include:

          Ambient Storage


          Controlled Room Temperature (20° to 25° C)


          Refrigerated (2° to 8° C)


          Frozen (-20° C)


          Ultra-Frozen (-80° C)


          Cryo Storage (-196° C)


          Other non-standard conditions available


          We can handle cytotoxic, highly potent and DEA Scheduled Materials (Category II-V).


          All storage areas are monitored 24/7.  Our facility includes a security system with motion sensors as well as restricted access throughout our facilities.

Global Distribution

We can prepare and ship your materials to any clinical study sites around the globe in the most cost-effective manner. Our partners are strategically positioned around the world, allowing for smooth shipping and customs release of your clinical supplies.  We deliver !


          Shipment of Temperature-Controlled Products Worldwide

          Pre-qualified shippers for up to 120 hours, at temperatures of -20°C, 2-8°C, and CRT

          Dry Ice (-70°C) or Gel Pack Shippers (2-8°C)

          Cryogenic Shippers

          Qualified Global Depots

          Temperature monitoring using the most advanced USB devices

          Web-based 3PL Inventory Monitoring System

Global Comparator Sourcing

PBLI offers extremely competitive pricing for comparator drugs through our relationships with qualified wholesalers and manufacturers around the globe. We can often secure comparator drugs that have constrained inventory so that your clinical trials proceed on-time. We can deliver comparators to your clinical sites in any design or configuration based on your needs. Your inventory will be maintained by PBLI using our 3PL web-based system ensuring timely and accurate data.

Returns, Reconciliations, Destruction

From start to finish PBLI can assist with your returns, reconciliation and destruction. Our GMP procedures and processes enable us to, work with each client to meet protocol-specific needs while ensuring compliance and safety.

          Our 3PL web-based inventory management system gives you access to your data at the push of a button.

          Full Reconciliation & Reporting

          Certified Destruction of Hazardous and Non-Hazardous Material

          Worldwide Returned Drug Accountability and Management

          Temperature-Controlled Returns (CRT, Refrigerated, Frozen)

          Return Kits

Clinical Packaging

We understand the complexity of getting your clinical trial material from CMO to clinical site. We can help with secondary packaging of virtually all dosage forms. Our cGMP procedures and processes enable us to efficiently and effectively meet your timeline while ensuring compliance and safety. No project is too big or too small for us to handle. We can offer faster and more flexible: Package Design Secondary Labeling Re-Labeling Kitting



Aliquoting Services

In addition to storing material, we can aliquot samples from bulk product while maintaining your GMP chain of custody. Drug Product Drug Substance (API)
Reagents Raw Material Powder, Lyo or Liquid

 

PACIFIC BIOPHARMA LOGISTICS

12760 Danielson Court, Suite F, Poway, CA 92064

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