Our technical staff makes project transitioning seamless. Our expertise enables us to scale up your process, and we’ll be there for you every step of the way. We also ensure that your work is held in the highest confidentiality.
In highly regulated markets, it is critical to have chemical manufacturing and research partners who understand the breadth of requirements to meet your needs.
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 65,000 square foot, state-of-the-art facility to our cGMP manufacturing and related services. Located on 45 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.
The innovative work our PhDs and chemists produce continues to expand the range of chemistry capabilities we can offer, such as:
- Free Radical Polymerizations for Emulsions and Solutions
- Condensation Reactions and Polymerizations
- Extraction and Purification processes
- Blending Operations
At Ortec, we realize it is not what we can do, but how we do it that makes a difference for our customers. For more detail on our capabilities, please click on the links below.