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ISO13485 / GMP Compliant Services

GenWay maintains ISO13485 accreditation for the development, validation, and production of antibodies and proteins for use in FDA regulated or CE mark products.

GenWay has developed and manufactured antigens and antibodies for use in IVD’s and also for assays used in development or testing of pharmaceutical and biotech products. Under the GenWay Quality System we work with clients in design control, development, validation, production, and testing of antibodies and proteins.

Please EMAIL or call us and tell us what you need so that we can work with you to design a program to meet your reagent development and production needs.