St. Renatus, LLC
Cold Chain Challenges for Combination Device Product
Challenge
As the approval date approached for St. Renatus’ revolutionary dental anesthetic (admitted through the nasal cavity), they asked Modality Solutions to help address cold chain management issues in a supply chain that did not traditionally handle a strict 2°C to 8°C product,
Objectives
- Cold chain capability assessments
- Strategic network design and recommendations for 3PL providers
- GDP compliance assessment
- Quality agreement
- Thermal packaging recommendations
- Prepare team for FDA pre-approval inspection
Results
See how Modality Solutions’ cold chain assessment helped St. Renatus achieve FDA approval for the first needle-free dental anesthesia.
Download the full case study