Roche's capacity for cost-effective manufacturing allows for the cost-efficient global delivery of products to meet the broad range of molecular laboratory testing needs. State-of-the art facilities located in Branchburg, New Jersey, US, enable Roche to remain ahead of production demands and provide an uninterrupted supply of products for customers.
Highest Quality Standards
At Roche, our products meet international quality standards, so there is a heightened focus on excellence through all stages of product development and manufacturing. Roche policies and procedures are designed to meet customer needs and to maintain compliance with all applicable regulations and international standards. Roche Molecular Diagnostics (RMD) holds licenses, certifications and registrations with the following agencies:
- US FDA registration as an IVD Specification Developer and IVD Manufacturer
- Center for Biological Evaluation and Research (CBER) license as a Biologicals Manufacturer (License No. 1636)
- ISO 13485:2003 and Canadian Medical Device Conformity Assessment System (CMDCAS): 1996 certification
- Japanese Pharmaceutical Affairs Law certification (Accreditation numbers AG30400176 and AG30400177)
Superior Service and Support
Rely on Roche for the stability and expertise you need.
- Timely flow of material
- Dedicated sales and logistics support
- Exceptional supply chain management
- Committed technical support