Successful regulatory inspections require both robust quality systems and well-prepared personnel who can confidently navigate the inspection process. Our approach to mock GxP inspections recreates the actual inspection experience, challenging your team with realistic scenarios and investigator techniques. We evaluate not only technical compliance aspects but also your team's inspection management skills, helping you develop a comprehensive inspection readiness strategy.
Our mock GxP inspection services include, but are certainly not limited to:
Thorough assessment of facilities and equipment against applicable GxP requirements.
Comprehensive evaluation of quality system documentation and records.
Realistic interview scenarios to prepare staff for interaction with actual investigators.
Direct observation of critical processes to identify potential compliance issues.
Focused evaluation of data management practices and controls.
Systematic review of quality system elements including deviations, complaints, CAPAs, and change control.
Targeted assessments of specific high-risk processes or previous inspection findings.
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.
