Regulatory enforcement actions require swift, thorough responses that demonstrate both immediate corrections and systemic improvements. Our approach focuses on developing comprehensive remediation strategies that address cited issues while strengthening your overall quality system to prevent future occurrences. We help you navigate complex regulatory relationships, develop credible response plans, and implement sustainable corrective actions that restore regulatory confidence.
Our regulatory response services include, but are certainly not limited to:
Strategic preparation of responses to FDA Form 483 observations.
Comprehensive planning and implementation support for addressing Warning Letter concerns.
Specialized guidance for companies operating under Consent Decree requirements.
Thorough investigation of compliance failures to identify underlying causes.
Targeted or end-to-end management of complex remediation initiatives.
Strategic preparation for meetings with FDA and other regulatory authorities.
Third-party assessment of remediation effectiveness prior to regulatory reinspection.
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.
