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.