Magellan Pharmaceutical Development provides a comprehensive, full-service and vertically integrated operation for clinical trials materials (CTM) preparation in support of Phase I through Phase IV studies. Magellan’s east and west coast facilities’ clinical packaging capabilities are cGMP compliant and include established Clinical Trial Material and Material Management SOPs with QA oversight.
Magellan Pharmaceutical Development has built a reputation as the premier contract pharmaceutical development organization by delivering quality science to its clients.
Magellan Pharmaceutical Development can help accelerate your pharmaceutical efforts by providing immediate resourcing and technical expertise in support of your product with flexible capacity and scheduling to meet your needs.
Please give us a call with any questions or submit a project
to us online for a cost estimate!
Core Capabilities
- Primary and Secondary Packaging
- Label Development and Printing
- Labeling and Assembly
- cGMP Warehousing and Product Storage
- Domestic and International Distribution
- Returns, Reconciliation, and Destruction
- Dedicated Analytical Laboratory Testing Services
Expertise
- Clinical Protocol Interpretation
- Clinical Supply Project Development
- Package and Label Design
- Material and Drug Product Sourcing
- Supply Chain Management
- Material Logistics; Ordering, Import, and Export
- Regulatory and Legal Issues
- International cGMPs/GCPs
- Randomization, including IVRS Systems
- Blinding Technique
s
- Site and Investigator Education and Training
- Consultation
Warehousing and Inventory Management
- cGMP Facilities and Systems
- Drug Product, Drug Substance, Raw Material, and Retain Sample Storage
- Controlled Room Temperature (15°C to 25°C)
- Refrigerated (2°C to 8°C)
- Frozen (-20°C, -70°C)
- Environmental Control and Monitoring in Warehouse and Processing Areas
- 24/7/365 Response for Excursions and Deviations
- Redundant Systems and Back-up Electrical Power
Packaging and Labeling
- Primary Packaging in Bottles and Blisters
- Drug Substance Dispensing and Filling
- Carton and Card Design
- Patient Kit Assembly
- Label Development, Printing, Application
Distribution to Investigators and Study Sites
- Domestic and International Distribution
- Refrigerated, Frozen, and HAZMAT Shipments
- Package Tracking and Proof of Delivery Verification
- Configured and Validated Product-Specific Shippers
- Fulfillment Trials
Returns
- Process Returns and Perform Reconciliation to Sponsor Specifications
- Storage, Disposition, and Destruction
