Internal
Supplier
QMS Gap Assessments
ISO 13485
21 CFR 820
ISO 9001
MDSAP Audit
EU MDR
EU IVDR
GMP Audit
GxP Audit
Mock FDA Inspection
M&A Due Diligence
Our approach prioritizes seamless, full-service support and adaptability to meet your unique objectives. With dedicated Project Managers, we oversee everything from single audits to comprehensive internal and supplier/vendor programs, including resourcing, scheduling, deliverables, and all details in between. Each audit is tailored to your specific needs and expectations, providing flexible solutions that integrate seamlessly into your operations. Our innovative “80/20” methodology focuses 80% on auditing and 20% on mentoring, empowering your team while driving actionable results for a truly value-added experience.
Backed by a team of seasoned auditors with 10 to 30 years of experience, including former FDA and Notified Body professionals, we ensure the highest level of expertise. Each auditor is rigorously vetted, and our experienced Project Managers, armed with over a decade of specialized knowledge, provide seamless oversight for every engagement.
We offer transparent, fixed-fee pricing with no hidden costs or unexpected change orders, ensuring peace of mind and financial clarity. Our Global Services span the Pharmaceutical, Medical Device, and Combination Product sectors, with expertise in a wide range of standards and regulations.
With a global network spanning over 30 countries and supporting 25+ languages, we are equipped to meet your needs no matter where you operate. In addition to auditing, we provide comprehensive support in remediation, SOP development, QMS optimization, CAPA support, training, mock FDA inspections, consulting services, and more.
We offer services designed to ensure your operations meet the highest standards and are fully prepared for any inspection. Our global audit services include, but are not limited to:
Internal
Supplier
QMS Gap Assessments
ISO 13485
21 CFR 820
ISO 9001
MDSAP Audit
EU MDR
EU IVDR
GMP Audit
GxP Audit
Mock FDA Inspection
M&A Due Diligence
We collaborate with your team to develop corrective action plans that address identified issues and improve overall compliance.
Our experts provide ongoing support throughout the remediation process, ensuring that all corrective actions are implemented effectively and in full compliance with applicable laws and regulations.
Our dedicated and experienced Project Managers save you time by managing every aspect of your audit from start to finish.
Whether it is an internal or supplier audit, our team begins with a kick-off call to review scope, gather the necessary documentation, assess procedures, and provide a detailed plan to ensure your organization is fully prepared for a comprehensive audit.
Our auditors will conduct your audit according to the agreed scope and expectations provided, addressing any areas of concern. We ensure continuous communication with you and your team throughout the audit, particularly if any concerning findings are identified.
Upon completion of the audit, you will receive a peer-reviewed draft report detailing the audit results, including any non-conformances, gaps, and areas for improvement, while ensuring compliance against applicable standards and regulations.
Our Project Managers will facilitate the electronic signing of the final audit report in compliance with Part 11 regulations. Once signed, the report will be distributed to all approved parties.
