Quality & Ethics

Manufactured in ISO-certified clean rooms under a robust Quality Management System. Processes align with international regulatory standards and include comprehensive testing for safety and consistency.

All umbilical cord tissue is donated after healthy, full-term births with full informed consent.

Low passage MSC processing ensures potency and biological integrity. Products are designed for research use and permitted clinical applications in accordance with regional regulations.

PROCESS DEVELOPMENT & REGULATORY SUPPORT

Navigating Expanded Access IND pathways and clinical phase manufacturing requirements can be complex. MediLabTec provides process development services to support:

• Establishment of clinical phase-appropriate cGMP processes
• Knowledge transfer and technology alignment
• Scale-up and commercialization strategies
• Integration into existing hMSC-based therapeutic programs

Our objective is to provide robust, cost-effective systems that allow partners to focus on product development and market advancement.

Products are manufactured in accordance with applicable international standards for Advanced Therapy Medicinal Products (ATMP) and related frameworks. Regulatory classification varies by jurisdiction and intended use.

Certain products may be designated for research use only (RUO). They are not intended to diagnose, treat, cure, or prevent disease unless authorized by appropriate regulatory authorities.

Contact:
MediLabTec info@medilabtec.com