Applications for Human Use

All of our standard (non-cGMP) products are intended for investigational use only. Persons intending to use standard Omicron products in applications involving human subjects assume the responsibility for these applications, and are required to comply with appropriate regulations, guidelines and procedures. Regulatory agencies should be consulted for pertinent information before conducting studies of this type. In some instances, approval may need to be obtained from the U.S. Food and Drug Administration (U.S-based studies) or from similar agencies in the country where the studies are to be conducted. Omicron will supply supporting information (general details of synthesis, analytical tests, etc.) to assist groups in obtaining formal approval of their studies by these agencies. Upon request, Omicron will ultrafilter products that are to be tested for sterility and/or pyrogenicity for an extra fee. Persons intending to use our products for in vivo applications, especially in humans, are advised to have appropriate independent tests of the formulated and/or repackaged product conducted by a qualified agent prior to usage. Omicron will work on a confidential basis with groups conducting such tests.

cGMP Synthesis for Human Clinical Studies