nanoComposix operates under a robust quality management framework designed to support the development and manufacture of advanced nanomaterials for research and regulated applications.
Our certifications and licenses reflect our commitment to regulatory compliance, quality assurance, and continuous improvement.
- ISO 13485:2016 Certification
- FDA Drug Establishment Registration
- DEA Controlled Substance Registration
- State of California Drug Manufacturing License
ISO 13485 Certified Quality Management System
nanoComposix maintains ISO 13485:2016 certification, the internationally recognized standard governing medical device quality management systems.
This certification, issued by Perry Johnson Registrars, Inc., demonstrates our ability to consistently design, develop, and manufacture products that meet applicable regulatory requirements and customer expectations.
Our ISO 13485-compliant processes support:
- Documented manufacturing and quality procedures
- Traceability of materials and production lots
- Rigorous supplier qualification and oversight
- Continuous quality monitoring and improvement
This framework enables nanoComposix to support partners developing nanotechnology-enabled diagnostic assays, therapeutics, and other regulated technologies.
Federal Registrations
FDA Drug Establishment Registration
nanoComposix is registered with the U.S. Food and Drug Administration (FDA) as a Drug Establishment. This registration affirms that our manufacturing operations comply with FDA requirements for facilities involved in the production of drug-related materials.
DEA Controlled Substances Registration
nanoComposix holds a registration with the U.S. Drug Enforcement Administration (DEA) authorizing the handling of controlled substances for research and manufacturing activities.
Registration details available upon request.
California Drug Manufacturing License
nanoComposix holds a Drug Manufacturing License issued by the State of California.
This license authorizes nanoComposix to manufacture drug-related materials within the state under regulatory oversight. Compliance with California state regulations complements our federal regulatory registrations and reinforces our commitment to maintaining high standards in manufacturing and quality control.
View Drug Manufacturing License
Updated certificate pending processing
Commitment to Quality and Compliance
nanoComposix integrates regulatory compliance and quality management throughout all stages of product development and manufacturing. Our facilities, personnel, and processes are structured to ensure:
- Reliable and reproducible nanomaterial production
- Regulatory alignment for diagnostic and therapeutic applications
- Comprehensive documentation and traceability
- Continuous improvement through quality monitoring and internal audits
This commitment enables nanoComposix to serve as a trusted partner for organizations developing nanotechnology-enabled innovations.
Partner with nanoComposix
Connect with our team to discuss your application and how nanoComposix can support your development and manufacturing needs.