At Specialty PharmaSource, we are exclusively focused on supporting global clinical trial supply requirements. From sourcing and managing critical materials to manufacturing, packaging, labeling, storage, and worldwide distribution, we provide fully integrated, end-to-end clinical supply solutions.
Our mission is to deliver reliability, regulatory precision, and operational excellence while maximizing value for sponsors and CRO partners worldwide
(1) Clinical Supplies Sourcing
We specialize in complex, allocation-controlled, and hard-to-source products, including materials affected by global shortages. Our team manages full chain-of-custody documentation, import/export compliance, and regulatory justification support to ensure uninterrupted trial continuity.
- Reference Listed Drug (RLD) Products
- Comparator Drug Products (Global Markets)
- Biologics & Temperature-Sensitive Products
- Specialty & REMS-Restricted Products
- Controlled Substances
- Drug Shortage Products
- Unlicensed / Named-Patient Medicines
- Clinical Trial Ancillaries and Support Supplies
(2) Clinical Manufacturing & Logistics
Our GDP-compliant infrastructure ensures product integrity, temperature control, and complete supply visibility across regions.
- cGMP Clinical Supplies Manufacturing
- Primary & Secondary Packaging
- Blinding & Randomization Support
- Global Labeling & Regulatory-Compliant Artwork
- Worldwide Distribution & Import/Export Management
- Controlled & Ambient Drug Product Storage
- Cold-Chain & Ultra-Low Temperature Handling
(3) Global Consulting Services
We help sponsors anticipate and manage allocation risk, shortage exposure, and cross-border regulatory complexity.
- Comparator Strategy & CREATES Act Support
- Drug Shortage Mitigation Strategy
- BE/BA Program Support
- Clinical Study Material Strategy
- Regulatory Documentation & Sourcing Justification