Ortec can help you foster your product from early process scale-up through full production while maintaining a high level of confidentiality. We have the expertise to help you through process validations and qualification, and we've manufactured products under FDA Regulations CFR 210, 211, 810 and 110. We constantly review new regulatory practices to ensure compliance.
Ortec has dedicated a 35,000 square foot, state-of-the-art facility to our cGMP manufacturing and related services. Located on 30 acres, this plant includes laboratories, pilot manufacturing suites and full-scale production areas. All chemical handling sections are designed as low particulate environments with 95% filtered air. Our 2,500 square foot validated Class 100,000 clean room contains USP Water and UV-filtered lights and windows.
to learn more about our cGMP Solutions. Or read more about the Analytical Services
we offer. More information is also available on our equipment capabilities