Clinical Supply Management
Clinical Supply Management
We are fully equipped to handle all your clinical supply chain needs. As your end-to-end clinical supply chain service provider, our clients encounter lower rate of failure and delays, saving you considerable time and money. Our service offerings include:
- Formulation development
- Analytical method development
- Phase-appropriate analytical method validation
- Selection and procurement of all raw materials and packaging components for cGMP clinical supplies manufacturing, with all required regulatory documentation (vendor statements, letters of authorization)
- Setting specifications for clinical supply materials
- cGMP Phase I, Phase II, or Phase III clinical supplies manufacturing for non-sterile materials
- Clinical and blinded clinical packaging
- Clinical supplies release testing with Certificate of Acceptance (COA) issuance
- Clinical supplies shipping to site or CRO (foreign clinic exports included)
- Clinical supplies shipping to site or CRO (foreign clinic exports included)
- Initiation of regulation stability studies on clinical trial materials
- Complete IND writing, including CMC sections
- FDA IND submission.
- Concurrent clinical material stability studies to ensure they remain within expiration dating to support the study.
- End-to-end Clinical supply chain project management
