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 your company is at pre-clinical, clinical or commercial stage, 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 hands-on support, we additionally provide personnel with full-range GxP expertise to work directly under your QMS on a mandate basis, including support with CDMO/CRO/CMO and distributor oversight.

For companies looking to launch a product in Europe, we provide strategic support to determine the required licenses in addition to preparing your QMS for a successful inspection to obtain European manufacturing and distribution authorizations. 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. Beyond initial launch, our team provides continued support for maintenance/governance of key quality systems and oversees your product while on the market.

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 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 tailored GxP training programs, we also ensure your team maintains up-to-date knowledge on GxP standards.