How can JensonR+ help you?
A sound Quality Management System (QMS) is a legislative GxP requirement and enhances organisation through an iterative process of continuous improvement.
We provide European Union batch release and certification by a Qualified Person, in addition to importation and retesting and can help you manage your Brexit requirements. We also have a number of experienced, Gold Standard trained Responsible Person (RPs) and can provide Responsible Person services to support your Good Distribution Practice (GDP) supply chain. We conduct Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Vigilance Practice (GVP) and Good Laboratory Practice (GLP) auditing as appropriate for drug substance manufacturers, drug product manufacturers, laboratories, warehouses and CROs. We also conduct Good Automated Manufacturing Process (GAMP) auditing to ensure your automated systems and websites are compliant.
We provide services across a company’s life cycle from helping emerging companies set-up quality systems and generate Standard Operating Procedures (SOPs) to assisting mature companies review batch records and audit suppliers. We ensure that you sustain a state of Inspection readiness by ensuring that you have a robust and effective quality system and vendor management program in place. Our team can also provide mock inspection services to prepare your organisation for any upcoming inspections.
Our Technical team can review and implement quality management systems and conduct risk management assessments, and we can even act as your quality department for companies needing to outsource technical activities. We have experience in complying with the EC Falsified Medicines Directive and can support you with product serialisation.
For companies with in-house teams, you can utilise our specific training and mentoring services to ensure your personnel meet the standards required by industry.