Regulatory requirements constantly evolve, making it challenging to maintain complete compliance across all aspects of your quality system and operations. Our systematic gap analysis methodology examines each element of your quality system against current regulations and industry best practices to identify areas needing improvement. We then create practical, risk-based remediation strategies prioritizing critical issues while considering resource constraints and business objectives.
Our gap analysis and remediation services include, but are certainly not limited to:
Comprehensive evaluation of compliance status against FDA regulations, ISO standards, EU MDR, and other applicable requirements.
Targeted analysis to prepare for upcoming regulatory inspections by identifying and addressing potential findings.
Strategic planning and implementation support to address inspection or audit observations and prevent recurrence.
Detailed review of quality management system elements against regulatory requirements.
Focused assessments of specific processes such as validation, complaint handling, or CAPA.
End-to-end management of remediation activities, including planning, execution, and verification.
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 (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.
