Need expert help identifying and remediating shortfalls within your Quality Management System (QMS)? Need to build or augment your Quality Assurance team with top talent? We help thousands of life science companies outsource their QA projects and fill specialized roles through convenient staff augmentation and recruitment.
Our quality and compliance specialists have extensive knowledge and experience in relevant regulations, guidances, and best practices related to quality system management throughout the regulated life science industries.
GxP Audits
QMS Process & Procedure Development
Gap Assessments
QMS Remediation
Quality Unit Resourcing
Our quality, manufacturing, CAPA, and supplier quality experts conduct comprehensive process reviews and analyses to ensure all compliance gaps are closed no matter where they may be.
Process Analysis & Enhancement
Investigation, Action Plan, & Effectiveness Check
Move your organization forward while maintaining a continuous and complete state of regulatory compliance. From regulatory observation responses to inspection readiness, our large staff of compliance specialists can tackle virtually any regulatory challenge.
Regulatory Observation Responses & Remediation
PAI & Inspection Readiness
Internal Audit & Remediation Services
Put your projects in the hands of qualified third-party experts. Outsourced project-based 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.
Our resources can be utilized to meet the wide range of quality assurance requirements, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.
Please contact us to learn more about fulfilling specific quality assurance resourcing needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.
Proprietary talent selection of former FDA and industry professionals amplified by a corporate culture of responsiveness and execution.
US Toll-Free: 1-833-FDA-GROUP
International: +001 508 926 8330