Cleanroom Manufacturing
ISO-certified, GMP-compliant facilities for aseptic processing.
Advanced Processing Techniques
Decellularization, lyophilization, or sterilization processes based on client requirements.
Batch and Lot Tracking
Rigorous documentation for full traceability.
Private Labeling Services
Branding support for clients' proprietary products.
Manufacturing and Processing Services
Scalability and Flexibility
Small Batch to Large Scale Production
Capabilities to meet the demands of startups, mid-sized companies, and large enterprises.
Customization and Adaptability
Flexible manufacturing processes to accommodate changes in clinical or commercial requirements.
Training and Education
Onboarding for Client Teams
Training on HCT/P product handling, storage, and usage.
Comprehensive HCT/P Product Development
Tissue Sourcing and Procurement
- Ethical and regulatory-compliant acquisition of donor tissues.
- Management of donor screening and testing to meet FDA and AATB guidelines.
Custom Product Design
- Tailored processing methods for amniotic tissues, placental tissues, and other HCT/Ps.
- Collaboration with clients to develop product formulations that meet specific clinical needs.
Regulatory Support
- Assistance with IND, IDE, and BLA submissions (as applicable).
- Guidance on FDA 21 CFR Part 1271 compliance.
Quality Assurance and Compliance
Rigorous Quality Control Testing
- Sterility, biocompatibility, and functionality testing.
- Endotoxin and microbial contamination assessments.
Documentation and Certification
- Support for compliance audits and inspections.
- Creation of comprehensive product dossiers and Certificates of Analysis (COAs).
Third-Party Audits and Validation
Independent audits to validate processes and regulatory compliance.
Additional Offerings
We provide end-to-end solutions to ensure seamless product development and commercialization, helping clients bring high-quality, compliant, and effective regenerative medicine products to market.
supply chain management
Add multiple feature items, set different icons or images for each feature and also give custom links if needed.
private labeling
Choose your style from three different layouts and two unique icon background shapes.
supply chain management
Add multiple feature items, set different icons or images for each feature and also give custom links if needed.
private labeling
Choose your style from three different layouts and two unique icon background shapes.
R&D Support
Show a connector line between each icon, changes its color and style to fit your unique design.
strategic partnerships
Ensures seamless product development and commercialization
R&D support
Show a connector line between each icon, changes its color and style to fit your unique design.
strategic partnerships
Ensures seamless product development and commercialization
