Certifications

An unwavering commitment to quality and evolving industry requirements.

Logos of certification groups

Life Science Outsourcing’s Certifications

As an FDA registered and ISO 13485 certified facility, we maintain the following certificates as part of our quality system.

FDA CDRH Registration: Contract Manufacturer, Contract Sterilizer
CDER Drug Sterilization Registration
State of California: Device Manufacturing License
State of California: Drug Manufacturing License
International Standard ISO 13485:2016
International Standard ISO 17665-1:2006 Moist Heat Sterilization
International Standard ISO 11135:2014 Contract Ethylene Oxide Sterilization and Validation Services
Japan Minister of Health: Medical Device Manufacturer, Sterile and Non Sterile Devices.
ISTA Certified Package Testing Laboratory
California Board of Pharmacy: Drug Wholesaler License
California Water Boards: General Permit to Discharge Storm Water

Let’s work together

Life Science Outsourcing prides itself on our role as partners in bringing medical innovations to life. That partnership forms the foundation of what sets us apart.