Gxp Quality Systems, Llc

GXPQS is an independent consulting company dedicated to partnerships in Biopharmaceutical Development with a unique, practical Quality System approach. We provide consulting services and assist Clients in setting up phase-appropriate quality systems to companies developing Drug Products (including Botechnology-derived and Biologic products), Combination Products, Medical Devices, Drug, Vaccine, Combination Products and cosmetics in research and development and commercialization phases of development. We follow the same processes internally that we recommend to Clients in terms of vendor oversight and personnel training our partnerships and collaborations with vendors and other service providers are robust, efficient and compliant. We ensure sustainability of both the Client’s QS and GXP-related activities by developing an overall plan for implementation in partnership with our clients. The plan contains specific deliverables at agreed timepoints, as well as training and development of the client’s personnel to maintain efficient future operations and the continuous improvement of the Quality System.