The pre-approval inspection represents a critical gateway for bringing new products to market, with significant business implications tied to the outcome. Our approach to mock PAIs focuses on creating realistic scenarios that challenge your team and systems in the same ways FDA investigators will during the actual inspection. We evaluate your facilities, quality systems, and application-specific elements against current regulatory expectations, helping you address gaps before they become inspection observations.
Our mock PAI services include, but are certainly not limited to:
Thorough evaluation of manufacturing facilities, equipment, and systems against PAI expectations.
Critical examination of submitted information against on-site reality to identify potential data integrity concerns.
In-depth assessment of process validation documentation, data, and implementation.
Detailed review of testing methods, data, and controls referenced in your application.
Realistic interview scenarios to prepare staff for interaction with FDA investigators.
Evaluation of quality systems with a focus on elements critical to application approval.
Comprehensive documentation of observations with remediation recommendations and optional execution support.
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.
