GxP Auditing Services
Throughout each phase of the product development and commercialization lifecycle, companies are facing significant compliance challenges. With our successfully tested processes, ProPharma Group can provide audit and assessment reports that quantify your strengths and areas of needed improvement.
Whether planned or unexpected, you should always be ready for a regulatory inspection. Preparations for these inspections can be done by planning audit activities to ensure that both compliance and performance are assured, and corrective/preventive actions can be taken at an early stage. This way you and your colleagues are prepared to face the inspectorate as they make their way through your facility and documentation.
ProPharma Group is your global partner for all audit needs at any time. Partner with an experienced and knowledgeable audit team that will help you become and stay compliant. From 2018 to 2019, ProPharma Group’s team of more than 100 global auditors have conducted audits in multiple languages, in all continents of the world. We can support your organization in end-to-end quality and compliance activities in any GxP area. Each auditor has extensive audit and operational experience in at least one of the GxP areas (GLP, GCP, GMP, GDP, GVP, and/or IT/CSV) and often combine this with knowledge of other areas within the pharmaceutical industry.
Our GxP Service Offering
Our quality and compliance audit services may include compliance audits, mock inspections and gap analyses for full GxP activities including GLP, GCP, GMP, GDP, GVP, and/or IT/CSV. Our mock inspections include, amongst others, mock FDA, EU, Middle East, or other relevant international regulatory agency inspections.
Other GxP services include development of a dedicated quality management system, training, interim quality management, validation and ad hoc GCP (QA) support. Our experts can also provide remediation support after an audit where findings/CAPAs need to be resolved.
Don’t risk potential gaps in your company’s compliance. Are the systems in your GxP area constantly in a state of inspection readiness? Is every colleague trained according to the required standards? Are your suppliers and clinical sites appropriately audited? Have a look at our brochure for more information and contact the compliance experts at ProPharma Group.