Quality Systems Consulting Services
Quality Systems Consulting Services is dedicated to partnering with clients in the medical device and pharmaceutical industries to ensure they achieve and remain in regulatory compliance. They offer expertise in regulatory compliance, quality control, remediation solutions, operational excellence, validations, business strategies, and legal services. Their mission is to exceed client expectations through sound guidance and hands-on assistance, delivering revenue-neutral compliance by leveraging extensive FDA and industry experience and operational excellence.
Industries
Nr. of Employees
small (1-50)
Quality Systems Consulting Services
Services
Regulatory compliance consulting
Consulting to achieve and maintain regulatory compliance, manage inspections and enforcement responses, and support regulatory submissions.
Quality systems auditing and gap assessments
Onsite and remote audits covering management, supplier, production, verification, certification, and due diligence audits with formal gap assessments.
Validation excellence
End-to-end validation services including planning, protocol/report development, execution of validation activities, and packaging of validation materials.
Operational excellence programs
Deployment of Lean, Six Sigma, Balanced Scorecard and related process-improvement programs to increase efficiency and reduce operating costs.
Remediation solutions
Rapid remediation planning and implementation for companies facing regulatory findings or enforcement actions, including sustainable corrective actions.
Business strategy and support
M&A due diligence, post-merger QMS integration, performance analysis, and temporary staff augmentation.
Regulatory compliance consulting
Consulting to achieve and maintain regulatory compliance, manage inspections and enforcement responses, and support regulatory submissions.
Quality systems auditing and gap assessments
Onsite and remote audits covering management, supplier, production, verification, certification, and due diligence audits with formal gap assessments.
Validation excellence
End-to-end validation services including planning, protocol/report development, execution of validation activities, and packaging of validation materials.
Operational excellence programs
Deployment of Lean, Six Sigma, Balanced Scorecard and related process-improvement programs to increase efficiency and reduce operating costs.
Remediation solutions
Rapid remediation planning and implementation for companies facing regulatory findings or enforcement actions, including sustainable corrective actions.
Business strategy and support
M&A due diligence, post-merger QMS integration, performance analysis, and temporary staff augmentation.
Expertise Areas
- Regulatory compliance and submission support
- Quality management systems (QMS) development and audits
- Operational excellence (Six Sigma, LEAN, Kaizen)
- Process and manufacturing validation
Key Technologies
- Applied statistics for quality
- Six Sigma methodologies
- LEAN manufacturing techniques
- Kaizen events