ProPharma Group and The Planet Group announce unified brand and expanded capabilities. Learn more > Home /Life Science Consulting /Pre-Approval Inspection and GxP Audits Pre-Approval Inspection and GxP Audits Helping You Meet Regulatory Compliance Expectations Any firm associated with regulated activities such as clinical studies, manufacturing of pharmaceutical products or medical devices, production of raw materials, or laboratory services requires routine inspection and GxP audits. Pre-approval inspections are a large part of inspections and your license to operate and commercially manufacture products. Such companies are expected to be compliant and continuously improving. As your partner, we can maintain alignment with new, existing, and changing regulations and industry standards that evolve throughout the drug product and device lifecycle. Global Expertise Across the Regulatory Spectrum Our team of specialists includes former FDA inspectors and CQA certified auditors who are proficient in conducting mock inspections, internal audits, vendor and supplier auditing, and gap assessment services. We serve as an extension of an organization’s Quality Department with respect to vendor and supplier auditing or act as a mock regulatory agency representative with respect to preparing your organization for an agency inspection. Partnering in a constructive and collaborative manner, we work together to understand, identify, and evaluate systems for quality improvements. Contact Us PRODUCT LIFECYCLE Expertise at every stage. Development Clinical Commercial HELPFUL LINKS Contact Us Blog Events COMPANY NAME JOB TITLE EMAIL ADDRESS Careers Language: Cookie Policy This website uses cookies to optimize website functionality, improve user experience, provide social media features, and analyze site traffic. You can at any time change or withdraw your consent from the cookie statement on our website. For more details, check our Privacy Policy. ACCEPT MANAGE PREFERENCES Reject