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GenCure has extensive experience in cGMP-compliant biomanufacturing and world-class quality systems. Our in-house quality and regulatory staff is experienced in interacting with and providing submissions to the appropriate regulatory agencies, allowing for a smooth transition from pre-clinical and clinical evaluation to commercialization. Your organization will also benefit from the experience of our established cGMP-compliant/ISO-certified quality management system.
GenCure supports a fully cGMP-compliant environment. Since our inception in January 2015, GenCure has received zero observations during regulatory inspections. We have also had numerous audits from accrediting agencies, clients and partners (including ISO).