Packaging and Labeling  - NEW!
RMC is now offering secondary GMP labeling and packaging for clinical Phase I/II materials. We've recently modified the lab to provide a dedicated packaging and labeling area with segregated working spaces. We only provide early stage secondary labeling/packaging/distribution services; therefore our costs are commensurate with this stage of development.  If you're looking for a cost-effective solution to your early stage clinical product labeling needs, we can help.
     - We develop Project Execution Protocols specific to your needs utilizing GMP compliant documentation systems to capture all stages of the process from product receipt to final distribution
 
     - We provide kitting services for multi-component clinical product kits
 
     - We arrange shipment of your temperature controlled material to your approved clinical site
 
     - Our lab space utilizes controlled and monitored temperature conditions
 
     - We can store your materials in a segregated and secured manner under controlled and monitored conditions.
     
 
     - Our GMP operations are compliant with: 
          
               - Applicable Labeling and Packaging Operations requirements as described in Title 21, Part 211 of the Code of (US) Federal Regulations current Good Manufacturing Practices (21CFR211)
 
               - Annex 13 of Volume 4 of the EU Guidelines to Good Manufacturing Practice 
 
               - EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C  63/03)
 
               
      
     - Our team members have prior experience with secondary labeling/packaging/distribution of clinical trial materials within the US, Canada, Europe, and Asia.