Quality Management System Services

Helping you maintain compliance, reduce risk, and ensure quality excellence

In today’s highly regulated life sciences industry, maintaining a robust Quality Management System (QMS) is essential for compliance, operational efficiency, and business success. Whether you need part-time quality support, regulatory transition assistance, or post-acquisition integration, our expert QMS solutions help you stay compliant while optimizing your quality processes. Our team has extensive experience in regulatory compliance, quality management, and life sciences industries. We provide customized solutions that are tailored to fit your organization’s unique needs and challenges. Our flexible engagement options are available for short-term projects, ongoing support, or full-scale QMS development.

Our Specialized QMS Services

Part-Time Quality Personnel

Not every organization requires a full-time quality team. We provide experienced part-time quality professionals to support companies in:

• Academic settings that require periodic quality oversight.
• Small or growing organizations that need temporary quality support.
• Companies facing staff shortages or interim quality leadership gaps.

FDA Migration to ISO 13485 Compliance

With the FDA aligning its Quality System Regulation (QSR) with ISO 13485, many organizations must transition to meet the new requirements. We help:

• Evaluate your current QMS and identify gaps in compliance.
• Develop a transition strategy to meet ISO 13485 standards.
• Implement necessary documentation, training, and process updates.

FDA Warning Letter Support

Receiving an FDA warning letter can be overwhelming, but our team is here to help. We assist companies in:

• Understanding and addressing compliance deficiencies.
• Developing Corrective and Preventive Actions (CAPA).
• Preparing for regulatory follow-up and audits to avoid further penalties.

GLP Compliance for Academic & Research Institutions

Many academic institutions and Medical Device (MED) suppliers struggle with achieving Good Laboratory Practice (GLP) compliance. We provide:

• Compliance assessments to identify gaps in GLP adherence.
• Custom QMS frameworks for research and testing facilities.
• Training and documentation support for full GLP implementation.

Good Tissue Practices (GTP) Compliance

If your facility is involved in the processing, storage, or distribution of human tissues and cellular products, you must comply with Good Tissue Practices (GTP). We assist with:

• Facility audits and readiness assessments.
• Regulatory documentation and SOP development.
• Staff training and process optimization to meet compliance standards.

Quality System (QS) Development, Support & Audits

A strong Quality System (QS) is the foundation of compliance and operational success. We provide:

• Full QMS development and implementation tailored to your organization.
• Ongoing support and maintenance for existing QMS frameworks.
• Internal audits, supplier audits, and mock regulatory inspections.

 Post-Acquisition Integration & Due Diligence

Mergers and acquisitions bring significant quality and regulatory challenges. We help organizations with:

• Pre-acquisition due diligence to assess compliance risks.
• Seamless integration of Quality Systems post-acquisition.
• Aligning processes, training, and documentation across merged entities.