Clinical Storage Distribution
Capable of manufacturing solid, liquid, and semi-solid dosage forms, BioDuro – Sundia’s Drug Product Manufacturing team provides a comprehensive service for clinical trial material preparation in support of Phase 0 to Phase II studies. Our contract pharmaceutical manufacturing services are cGMP compliant and include established clinical trial material management SOPs with QA oversight.
Clinical Storage & Distribution
- Coupled with BioDuro-Sundia’s partnership with ABF pharmaceuticals, our cGMP validated and monitored warehouse allows us to provide seamless supply chain management resources to our clients. Our San Diego based cGMP warehouse will give you quality pharmaceutical warehousing, while our partners at ABF provide seamless clinical distribution services. Our close partnership with ABF enables us to provide our clients with a simple solution to complex clinical trial supply problems.
Services
- Clinical trial supply services
- GMP audits
- Import into EU and QP declaration as well as QP release
- Comparator sourcing
- Primary and secondary packaging according to EU- GMP
- Labeling / relabeling according to EU- GMP (ambient / cooled / frozen storage conditions: -20°C/-80°C)
- In house EU- GMP label production incl. label text translations according to country specific guidelines
- Blinding / randomisation
- Storage according to EU GMP (ambient / cooled / frozen storage conditions: -20°C/-80°C) and controlled drugs
- Import and export
- Temperature controlled worldwide shipments according to GDP
- QP-Services for Investigational Medicinal Products, pharmaceuticals with marketing authorization, controlled pharmaceuticals and medical devices
- PBMC
- Central laboratory supply
Storage Capabilities
- cGMP pharmaceutical warehousing equipped with controlled access cages
- Cold-chain inventory management – refrigerated and frozen capabilities
- Coordinated project management system
- Raw materials release and handling