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Quality Controls
Quality, Compliance & Processing Standards
TheroGenX is committed to maintaining rigorous standards of quality, safety, and process control across all human tissue allograft materials.
Regulatory Alignment (U.S. & International)
TheroGenX operates in alignment with:
- U.S. Food and Drug Administration (FDA) regulations
- 21 CFR Part 1271 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
- Current Good Tissue Practices (cGTP)
- International regulatory expectations for human tissue products
Our systems are structured to support compliance with both U.S. regulatory frameworks and international market requirements.
Quality Management System (QMS)
Our operations are guided by a comprehensive Quality Management System designed to support:
- Product consistency and controlled outcomes
- Full lifecycle traceability
- Continuous quality improvement
Our QMS incorporates principles aligned with:
- ISO 13485 (medical-related quality systems)
- ISO 9001 (quality management and process control)
Good Manufacturing & Tissue Practices
TheroGenX follows industry-recognized standards for biologic processing:
- cGTP-compliant processes under FDA guidelines
- Environmental controls consistent with tissue processing standards
- GMP-aligned environments for controlled biologic handling
- Aseptic processing techniques
- Controlled and monitored production conditions
- Defined and controlled workflows across sourcing, processing, and packaging
- Processed in accordance with applicable requirements under 21 CFR Part 1271.
These systems are designed to support product integrity, safety, and consistency across all batches.
Donor Screening & Tissue Qualification
All biologic materials are managed through defined qualification protocols:
- Comprehensive donor screening and medical review
- Infectious disease testing in accordance with regulatory standards
- Full traceability from donor to final product
- Controlled chain-of-custody procedures
Quality Control & Product Testing
Multi-level quality control systems designed to support defined specifications:
- Structural and visual evaluation
- Lot-to-lot consistency verification
- Environmental monitoring
- Sterility and bioburden testing (as applicable)
- Stability and storage validation
Traceability & Documentation
TheroGenX maintains a fully integrated tracking system providing:
- End-to-end traceability
- Lot identification and batch tracking
- Audit-ready documentation
- Regulatory transparency for partners
Storage, Handling & Distribution
All materials are managed under validated conditions:
- Controlled temperature storage environments
- Temperature-monitored logistics
- Protective packaging systems
- Chain-of-custody tracking
