Packaging and Labeling

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.