Our Services

We are the value leader providing support services to the clinical trial supplies market. Our core focus is on GMP labeling, packaging, storage and distribution of FDA regulated clinical trial IP and materials for the Pharmaceutical, Biotechnology & Medical Device Industries. Our 25,000 sq ft secure facility is monitored 24/7. It has been designed to quickly and accurately execute your clinical project. All GMP equipment is on a back-up generator system.

CLINICAL LOGISTICS SERVICES

Clinical Labeling, Packaging & Kitting:

Customized labeling solutions
Comprehensive packaging services
Kitting services for efficient clinical trial management

Aliquoting:

Precision aliquoting services for accurate sample distribution
Aliquot samples from bulk product while maintaining your GMP chain of custody. Drug Product Drug Substance (API)
Reagents Raw Material Powder, Lyo or Liquid

Global Comparator Sourcing:

Strategic sourcing of global comparators for clinical trials
Quality-assured comparator products for study consistency

GDP/GMP Storage:

Storage facilities adhering to Good Distribution Practices (GDP)
Good Manufacturing Practices (GMP) compliant storage environments

Global Distribution:

Efficient and reliable global distribution network
Timely and secure delivery to worldwide destinations

Returns, Reconciliation, Destruction:

Streamlined processes for handling returns
Accurate reconciliation services
Secure and compliant destruction procedures

Storage Solutions

Multiple Storage Conditions:

Small-scale Phase I to large Phase III studies catered to
Standard USP conditions:
- 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)
Customized non-standard storage conditions available

QUALITY
SYSTEMS

Flexible Approach to Compliance:

Compliance strategies based on extensive experience
Tailored systems to meet the unique needs of each development stage

Training, Qualified Equipment, Written Procedures for GDP/GMP:

Comprehensive training programs
State-of-the-art equipment qualified for GDP/GMP standards
Robust written procedures ensuring regulatory compliance

Compliance Master Plan:

Strategic master plan for ensuring and maintaining compliance
Proactive measures for anticipating and addressing regulatory changes

Systems Approach to Policies and Procedures:

Integrated systems for cohesive policies and procedures
Ensuring consistency and alignment across all operational aspects

Project Director Accountability:

Dedicated Project Director overseeing all project aspects
Direct accountability to the customer for seamless project execution

This detailed list outlines the comprehensive range of services provided by Pacific Biopharma Logistics, covering clinical logistics, storage solutions, and quality system approaches for successful clinical trial support.