Saccharides, Nucleosides, Derivatives
13C, 2H, 15N, 18O Labeling


cGMP Synthesis for Human Clinical Studies

Omicron Biochemicals has significant experience in the preparation of its labeled products that meet cGMP standards for use in human clinical studies. Because the details of these syntheses depend on the specific project, Omicron works closely with clients to develop final product specifications, and a plan for routine review and inspection of our processes as the work progresses. The latter would include client inspection of those cGMP documents pertinent to the project, including the Master Batch Record. We will also file DMF documents with the FDA if appropriate. Please inquire for a more detailed description of our capabilities.