AssureImmune
Comprehensive Solutions for Success
At AssureImmune, our team of scientists, technicians and account managers are leaders in the industry, providing expert consulting and project management from early concept development to product launch.
Our comprehensive list of products and services are designed to create a roadmap for success tailored to your specific needs. We partner with you to improve patient outcomes and quality-of-life.
With decades of cellular therapy experience, we cover cord blood and adult stem cell banking, regulatory affairs, INDs, IRBs submissions, quality assurance, cGMP facility design consulting, clinical trials monitoring (CRO) including but not limited to database management, medical monitoring management, DSMB formation and management.
We are with you every step of the way, navigating a complex system of federal rules and regulations with clarity, care and ease.
AssureImmune Products & Services
Storage Solutions
Service Solutions
- Peripheral Blood Mononuclear Cell (PBMC) Isolation for Global Clinical Trials
- Regulatory Affairs Consulting
- New Investigational Drug Application (IND) Submission
- CMC Maintenance & Quality Assurance
- Expanded Access
- IRB Submissions and Management
- Clinical Trial Monitoring (CRO)
- cGMP Facility Design
- Contract Manufacturing for Clinical and Pre-Clinical Projects
- cGMP|GTP|GLP Consulting
- Drug Master File (DMF) Submissions