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:
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Customized labeling solutions
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Comprehensive packaging services
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Kitting services for efficient clinical trial management
Aliquoting:
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Precision aliquoting services for accurate sample distribution
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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:
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Strategic sourcing of global comparators for clinical trials
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Quality-assured comparator products for study consistency
GDP/GMP Storage:
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Storage facilities adhering to Good Distribution Practices (GDP)
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Good Manufacturing Practices (GMP) compliant storage environments
Global Distribution:
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Efficient and reliable global distribution network
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Timely and secure delivery to worldwide destinations
Returns, Reconciliation, Destruction:
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Streamlined processes for handling returns
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Accurate reconciliation services
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Secure and compliant destruction procedures
Storage Solutions
Multiple Storage Conditions:
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Small-scale Phase I to large Phase III studies catered to
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Standard USP conditions:
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Ambient Storage
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Controlled Room Temperature (20° to 25° C)
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Refrigerated (2° to 8° C)
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Frozen (-20° C)
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Ultra-Frozen (-80° C)
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Cryo Storage (-196° C)
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Customized non-standard storage conditions available
QUALITY
SYSTEMS
Flexible Approach to Compliance:
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Compliance strategies based on extensive experience
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Tailored systems to meet the unique needs of each development stage
Training, Qualified Equipment, Written Procedures for GDP/GMP:
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Comprehensive training programs
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State-of-the-art equipment qualified for GDP/GMP standards
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Robust written procedures ensuring regulatory compliance
Compliance Master Plan:
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Strategic master plan for ensuring and maintaining compliance
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Proactive measures for anticipating and addressing regulatory changes
Systems Approach to Policies and Procedures:
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Integrated systems for cohesive policies and procedures
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Ensuring consistency and alignment across all operational aspects
Project Director Accountability:
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Dedicated Project Director overseeing all project aspects
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Direct accountability to the customer for seamless project execution