Full Service Support
With today’s stringent regulations in the medical and pharmaceutical industries, Red One has the operational footprint to immediately support your business. Red One has developed a complete logistical network including government distribution and warehousing operations.
Certified and Scalable Supply Chain
Red One operates from an ISO 13485:2003 certified facility that adheres to the cGMP regulations mandated by the FDA for all logistical storage requirements.
The Quality System is designed to comply with the applicable parts of ISO 13485, 21 CFR Part 820 Quality System Requirements, 21 CFR 801 (Labeling), 803 (Medical Device Report — MDR), 806 (Corrections and Recalls), 807 (Establishment Registration), FDA registered, cGMP Compliant, Parts 210 and 211, Full Validation Programs, Drug Filling Support, Full Tech Transfer Ready, DEA Licensed (CII-CV), and other regulatory and statutory requirements.
|Supply chain, distribution, and warehousing||EDI (Electronic Data Interchange) ready||Pharmaceutical repackaging and relabeling|
|24-hour operations||Cold chain logistics||Controlled-environment clean rooms|
|Inventory management||RFID and lot control||Quality and manufacturing management|
|Serialization and aggregation ready||Customer service and order to cash||DSCSA compliant|