Practical Regulatory Solutions for FDA-Regulated Industries
N&CS Consulting Group provides regulatory and compliance consulting services to pharmaceutical, medical device, and other FDA-regulated organizations.
We help organizations assess regulatory requirements, identify compliance gaps, strengthen quality systems, remediate deficiencies, and prepare for regulatory inspections and audits.
Our approach combines regulatory knowledge with practical engineering, validation, quality, and manufacturing experience—helping clients translate regulatory requirements into sustainable processes and effective quality systems.
Regulatory & Compliance Services
N&CS supports organizations throughout the compliance lifecycle—from initial assessment and gap analysis through remediation, implementation, and inspection readiness.
Regulatory Compliance Assessments
Evaluate existing processes, procedures, documentation, and quality systems against applicable regulatory requirements and industry standards.
We provide practical recommendations prioritized according to regulatory significance and business impact.
GMP & Quality System Compliance
Support for organizations operating under FDA current Good Manufacturing Practice (CGMP) requirements, including:
Our objective is not simply to identify noncompliance, but to help organizations develop effective and sustainable corrective solutions.
FDA Inspection Readiness
Prepare your organization for regulatory inspections through structured assessments and targeted remediation.
For medical-device manufacturers, our approach incorporates the FDA’s current QMSR inspection framework.
Is Your Quality System Ready for QMSR?
FDA’s Quality Management System Regulation (QMSR) became effective on February 2, 2026. QMSR amended 21 CFR Part 820 and incorporates ISO 13485:2016 into the FDA’s regulatory framework for medical-device quality management systems.
The transition represents an important change for medical-device manufacturers operating in the United States.
N&CS can help organizations evaluate their existing quality systems, identify areas requiring attention, and implement practical improvements aligned with QMSR and ISO 13485 requirements.
QMSR & ISO 13485 Services
QMS Implementation & Improvement
Support organizations implementing, upgrading, or continuously improving their quality management systems.
QMSR is now in effect. Let N&CS evaluate your current quality system and identify the actions needed to strengthen alignment with QMSR and ISO 13485.
Quality Systems & CAPA
Effective regulatory compliance depends on a quality system that works in practice—not simply a collection of procedures.
We focus on developing processes that are practical, risk-based, measurable, and sustainable.
Computerized Systems & Data Integrity
Modern regulated operations depend on computerized systems to generate, process, maintain, and report critical quality and manufacturing data.
Our approach is designed to help organizations establish confidence in the reliability, integrity, and intended use of computerized systems supporting regulated processes.
Validation & Qualification Compliance
N&CS provides validation and qualification services supporting regulated manufacturing, laboratory, utility, and computerized systems.
We help organizations establish documented evidence that facilities, equipment, utilities, processes, and systems are suitable for their intended use.
Regulatory Remediation
When a compliance issue has already been identified, organizations need more than a written response—they need a sustainable corrective solution.
Our remediation approach emphasizes root cause, risk, corrective action, effectiveness, and long-term sustainability.
Applicable Regulations & Standards
N&CS provides consulting support aligned with applicable regulatory requirements and recognized industry standards, including:
Standards and regulations are selected based on the client’s products, processes, facilities, systems, and applicable regulatory jurisdiction.
Why N&CS
Regulatory Knowledge. Engineering Experience. Practical Solutions.
Regulatory compliance is most effective when regulatory requirements are understood in the context of the actual manufacturing process, facility, equipment, systems, and quality organization.
N&CS combines regulatory and quality expertise with hands-on engineering and validation experience to help organizations solve complex compliance challenges.
Our consultants can work alongside your existing quality, engineering, manufacturing, validation, and regulatory teams to provide targeted support where it is needed most.
Our approach
Let’s Strengthen Your Regulatory Compliance Program
Whether you are preparing for an FDA inspection, addressing a quality-system deficiency, implementing QMSR, strengthening your CAPA program, or validating a regulated system, N&CS can provide the technical and regulatory support needed to move forward.
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