About Us

With over two decades in the healthcare industry helping develop and implement a wide range of quality systems as well as regulatory auditing and compliance programs, our team of seasoned professionals and CQA/CQE/Exemplar Global-certified consultants has the unmatched depth and breadth of knowledge that can only come from years of hands-on, sleeves-rolled-up experience. The expertise that is gained by this kind of industry experience enables us to provide our clients with unparalleled insight into regulatory compliance, auditing, and more efficient, effective quality programs that are individually tailored to each client and their business needs. As a result, they’re often able to bring their products to market more quickly and at lower cost, with less risk and greater success.

Our extensive quality consulting experience includes the implementation, remediation, and maintenance of quality systems in accordance with pharmaceutical and medical device regulations, including US FDA QSR, ISO 13485:2016, ISO 9001, MDR, 21 CFR 210 and 211, ICH, Health Canada, MDSAP, European pharmaceutical regulations, and other relevant standards and regulations.

Our services include:

• Regulatory strategy and compliance consulting
• MDSAP, ISO 13485, ISO 9001, 21 CFR 820 auditing
• Internal auditing
• Startup assistance and Quality Management System implementation
• Quality System, GLP, and GMP gap assessment and improvement
• Quality Management System Remediation
• FDA inspection and audit readiness and support
• MDR to MDD transition
• Quality Engineering services: stability studies, process and software validation, supplier evaluation and control, risk analysis, CAPA development and management
• Staffing support and contract services
• QMS Training