AnaSpec is well-equipped to assist you with the production of GMP-grade peptides for research-grade applications. Our experience, gained from the synthesis of many GMP-grade peptides, translates into the strong documentation and regulatory support your research applications demand. This expertise, coupled with our unique capabilities in large-scale synthesis and purification, enables us to provide you with pharmaceutical-grade peptides of exceptional quality in quantities ranging from milligrams to hundreds of grams. Along with the accompanying certificates of analysis for GMP-grade peptides, detailed procedures and drug master files will be provided for regulatory purposes. Certificates of analysis for all raw materials used in the manufacturing process are also provided. AnaSpec holds a FDA Registration for GMP Drug Manufacturing (Registration #2951078). All GMP-grade peptide production strictly follows GMP and ISO-9002 guidelines. Please call us to discuss your individual requirements. We welcome the opportunity to put our technical and regulatory experiences to work for you.
