ProPharma Group and The Planet Group announce unified brand and expanded capabilities. Learn more > Home /Regulatory Sciences /Pre-Approval Audits Pre-Approval Audits Why is Quality and Compliance Important? Independent clinical audits for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) compliance are part of an intelligent quality system framework and vital to product development. Current Food and Drug Administration (FDA) standards require that quality systems ensure safe drug manufacturing and clinical trial oversight; these systems must include established regulatory compliance and risk mitigation processes. Often, warning letters from the FDA or observations noted during an FDA inspection regarding noncompliance or nonconformance are a result of a dysfunctional quality system. Regardless of the specific situation you are experiencing, you need to respond quickly to protect the future of your product and company. We are able and ready to help you overcome these roadblocks that can occur during product development. FIND OUT HOW WE CAN HELP YOU Our experts are ready to tackle your challenge. Call Us Now Request a Call FIND AN EXPERT 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

ProPharma Group and The Planet Group announce unified brand and expanded capabilities. Learn more > Home /Medical Information /Other MI Services Other MI Services ProPharma Group partners closely with internal teams to support our clients’ customers and patients and provide first-in-class global MI services. Promotional Review We understand the importance of collaborating with clinical and commercial departments to improve communication and process efficiencies during the promotional review process. We partner closely with your team to review all forms of advertising and promotion for medical accuracy, comprehensiveness, and fidelity, as well as for legal and regulatory compliance with the FDA, EMA, and other applicable authorities. Congress/Booth Support 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