An unwavering commitment to quality and evolving industry requirements.
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.
International Standard ISO 13485:2016
FDA CDRH Registration: Contract Manufacturer, Contract Sterilizer
State of California: Device Manufacturing License
International Standard ISO 17665-1:2006 Moist Heat Sterilization
International Standard ISO 11135:2014 Contract Ethylene Oxide Sterilization and Validation Services
CDER Drug Sterilization Registration
State of California: Drug Manufacturing License
Japan Minister of Health: Medical Device Manufacturer, Sterile and Non Sterile Devices.
ISTA Certified Package Testing Laboratory
From Idea to Commercialization
From startups to multinational corporations, we’ve helped pharmaceutical companies and medical device makers of all sizes turn powerful ideas into profitable offerings. Our unique model serves as a turnkey solution offering unparalleled time to market through a full spectrum of regulated services and specialized high-value capabilities.