Chemic Laboratories, Inc. is a fully integrated cGMP/GLP contract chemistry organization located in Canton, Massachusetts, FDA registered and DEA licensed, servicing the pharmaceutical, biotech, veterinary medicine, medical device and specialty chemical industries.
Chemic’s scientific professionals have extensive experience in the completion of methods development, validation, product and process validation, usp testing, degradate and metabolite identification, extractables and leachables assessment, container closure assessment, bio-analytical analysis, small scale cGMP organic synthesis, formulation development, and high purity excipient manufacturing. All analytical and manufacturing programs are completed under the auspices of FDA and/or ICH guidelines. Investigative protocols customized for a client’s specific needs are offered and Chemic maintains the necessary licensing to receive controlled substances (Schedule I-VI) into our analytical facility as well as manufacturer Schedule II materials.
In addition to our contract testing and manufacturing services, we recognized a need for high purity lactate ester excipient products. Currently, the marketplace has materials available with purities insufficient for pharmaceutical, intermediate or reference standard purposes. Therefore, we moved our synthetic platform forward to accommodate and manufacture a line of high purity excipients through proprietary methodology.