Trust and Compliance

Comprehensive GxP Audit Services

Maintain regulatory compliance, improve operational excellence, and prepare for inspections with trusted guidance.

Meet global regulatory standards with specialized audit and assessment services that see further to future-proof your GxP operations.

USDM’s comprehensive GxP audit services provide life sciences organizations with end-to-end support to achieve and maintain regulatory compliance across all GxP domains—including clinical, manufacturing, quality, and IT systems. These services include mock audits, gap assessments, remediation planning, and ongoing compliance monitoring, all tailored to global regulatory requirements such as FDA, EMA, and ISO standards. USDM’s experts apply deep industry knowledge and proven frameworks to identify compliance risks, streamline documentation, and optimize processes. The result is a proactive, audit-ready environment that reduces regulatory exposure, supports operational excellence, and builds confidence with regulators and stakeholders.

Achieve Compliance and Readiness with Comprehensive Audit Support

Get end-to-end audit support and be prepared for regulatory inspections. Our team conducts mock audits, gap analyses, and continuous compliance monitoring to address any issues before they become findings. This proactive approach streamlines your audit processes, reduces compliance risks, and reinforces audit readiness year-round.

Resolve Compliance Gaps and Restore Regulatory Confidence

Address compliance gaps quickly and thoroughly to bring systems and processes up to regulatory standards. Our experts in remediation services collaborate with your organization to identify root causes, implement corrective actions, and prevent recurring issues with sustainable solutions. Resolving compliance gaps effectively means you’re able to minimize risk, avoid penalties, and maintain operational integrity.

Empower Your Team with GxP Training for Operational Excellence

Uphold Good Practice (GxP) standards across all regulated activities and equip your teams with the knowledge and skills to establish a culture of continuous quality. From foundational GxP principles to specific regulatory requirements, our customized GxP training programs prepare your teams to be audit-ready, maintain compliance, reduce risk, and improve productivity.

Mock Audits and Gap Analysis

At USDM Life Sciences, we believe audit readiness should never be reactive. Our mock audits and gap analysis services are foundational to a proactive compliance strategy —designed to help life sciences organizations identify, address, and mitigate potential issues before regulatory agencies do. Whether preparing for an FDA inspection, EMA audit, or internal quality review, we ensure our clients are inspection-ready at all times, not just when the calendar demands it.

Our approach begins with in-depth discovery sessions to understand your operational landscape, risk exposure, and regulatory history. From there, we execute comprehensive mock audits that simulate real-world regulatory inspections—evaluating documentation, processes, systems, and vendor oversight against applicable GxP regulations. Our seasoned auditors bring deep domain expertise across clinical, quality, manufacturing, regulatory, and IT, offering detailed insights into where gaps exist and how to resolve them quickly and effectively.

Through gap analysis, we go beyond surface-level findings to uncover root causes of compliance risks. We benchmark your operations against current industry best practices and global regulatory standards, providing a prioritized, actionable remediation plan tailored to your organization’s maturity, complexity, and risk profile. This enables you to close gaps strategically—optimizing compliance posture, risk management, and operational performance.

Our team doesn’t just deliver reports—we partner with you to execute change. From SOP enhancements and training programs to system remediation and vendor alignment, we provide end-to-end support to harden your audit defenses and foster a culture of continuous compliance.

By identifying vulnerabilities before they escalate, USDM empowers clients to stay ahead of regulatory demands, avoid costly findings, and maintain uninterrupted business continuity. It’s not about passing the next audit—it’s about being always audit-ready.

Vendor Program Management and Inspection Readiness

In the highly regulated life sciences landscape, audit readiness isn’t just an internal requirement—it’s a supply chain imperative. USDM Life Sciences takes a proactive, end-to-end approach to compliance by extending GxP oversight beyond your organization to every vendor and partner in your ecosystem. Our vendor program management and inspection readiness services are designed to ensure that your suppliers, CROs, CMOs, and technology partners meet the same rigorous standards you do.

We help life sciences organizations establish structured vendor qualification and governance programs that drive visibility, accountability, and consistency across all third-party relationships. From onboarding through ongoing monitoring, USDM implements risk-based oversight models, conducts mock audits, and identifies potential gaps before they become findings—ensuring a continuous state of audit readiness.

Our experts offer comprehensive inspection readiness services that include SOP alignment, role-based training, documentation cleanup, and real-time dashboards to monitor critical compliance indicators. We prepare internal teams and external partners alike for regulatory scrutiny from agencies such as the FDA, EMA, and Health Canada.

USDM integrates digital quality solutions like ProcessX to automate audit trail management, change control, and document workflows across your vendor landscape—empowering you to reduce risk and improve operational efficiency without sacrificing compliance.

With decades of experience and a deep bench of life sciences expertise, USDM ensures your organization and supply chain are aligned, audit-ready, and built for sustainable success. Whether you face a scheduled inspection or a surprise audit, our proactive strategies keep you confident, compliant, and in control.

Domain Expertise

Success Stories

A customer engaged USDM to provide regulatory expertise for vendor audits and qualification throughout the United States and world. Learn more.

80% decrease in auditing time

1 %

25% improvement in auditing compliance

1 %

$112K in annual savings

$ 1 K

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