At Luminance Health, our Quality team understands the complexity of continuously upholding GxP standards while navigating dynamic and international regulatory landscapes. Based on in-depth experience in establishing and maintaining diverse Quality Management Systems (QMS) for pharmaceutical, medtech and combination product companies, our team offers a holistic range of services that ensure GxP compliance at every stage of your product’s lifecycle.

Whether you require a first QMS, undergo QMS harmonization or prepare to enter commercial operations, our team provides tailored and pragmatic QMS development services that are compliant with international standards while also being appropriate for the size of your organization and your product pipeline.

For companies looking to obtain licenses for European manufacturing and distribution operations, we provide strategic support to determine license requirements in addition to preparing your QMS for a successful inspection. With our network of experienced Responsible Persons (RPs) and Qualified Persons (QPs) across the EU, UK and Switzerland, we also provide hands-on operational support for execution of your company’s standards and maintenance of your licenses.

Continuous improvement and adherence to procedures is paramount for ensuring product quality, patient safety and uninterrupted business operations. Through our comprehensive Quality Compliance offering, we provide auditing, mock inspection, inspection readiness and regulatory intelligence services to ensure your organization is always on top of the latest requirements and operating in state of compliance. For any cases of non-compliance, we additionally provide focused remediation advice and manage Health Authority interactions to ensure seamless operations. Through hands-on Quality Systems support, we also monitor the performance of your operations and manage change/continuous improvement initiatives.