Regular, thorough audits are essential to maintaining robust quality systems and preparing for regulatory inspections. Our approach focuses on conducting detailed, objective evaluations that identify both compliance gaps and opportunities for system optimization. We examine your processes, documentation, and quality systems through the lens of current regulatory expectations, helping you address potential vulnerabilities before they become compliance issues.
Our GxP audit services include, but are certainly not limited to:
Comprehensive evaluations of manufacturing facilities, processes, and systems against current Good Manufacturing Practice requirements.
Detailed assessments of laboratory facilities and operations for compliance with Good Laboratory Practice regulations.
Thorough reviews of clinical research activities to ensure compliance with Good Clinical Practice standards.
Evaluations of distribution operations against Good Distribution Practice requirements.
Focused reviews of documentation practices against Good Documentation Practice standards.
Specialized assessments of computerized systems for compliance with Part 11 and data integrity requirements
Simulated regulatory inspections that prepare your team for agency oversight.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant/contractor (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.
