Integrated Consulting, Engineering & Regulatory Expertise for FDA-Regulated Industries
N&CS combines regulatory compliance, quality systems, validation, engineering, manufacturing, and project management expertise to help life-science organizations solve complex technical and compliance challenges.
Four capability groups. Twelve specialized services.
Each service has a dedicated page so clients can move directly from the challenge they are facing to the expertise that can address it.
Regulatory & Quality
Regulatory Compliance
FDA regulatory compliance, GMP, quality systems, QMSR/ISO 13485 readiness, inspection preparation, and compliance assessments.
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FDA Remediation & Inspection Readiness
Experienced support for FDA 483 observations, quality-system deficiencies, remediation programs, Consent Decree initiatives, CAPA, and inspection readiness.
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Quality Systems & CAPA
Support for quality-system improvement, investigations, deviations, nonconformances, CAPA, change control, documentation, audit readiness, and quality-system effectiveness.
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GxP Consulting
Practical consulting support for regulated operations, including GxP compliance, quality systems, validation strategy, documentation, risk management, and implementation support.
Explore capability →Validation & Computerized Systems
Validation & Qualification
Comprehensive validation and qualification support for regulated facilities, equipment, utilities, processes, cleaning programs, and computerized systems.
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Computerized Systems & Validation
Risk-based validation and assurance of computerized systems supporting regulated processes, including CSV, CSA, electronic records, data integrity, and 21 CFR Part 11 compliance.
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Instrumentation & Calibration
Instrumentation and calibration support for regulated manufacturing and laboratory environments, including calibration programs, measurement systems, instrumentation assessment, and technical troubleshooting.
Explore capability →Engineering & Manufacturing
Engineering Services
Engineering support for regulated manufacturing and life-science operations, including process engineering, capacity and capability analysis, time studies, process improvement, equipment support, and technical problem solving.
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Pharmaceutical Manufacturing
Manufacturing engineering and technical support for regulated pharmaceutical operations, including equipment, processes, production systems, troubleshooting, optimization, and continuous improvement.
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Facilities & Utilities
Engineering, qualification, and compliance support for regulated facilities and critical utilities, including HVAC, purified water, compressed gases, environmental systems, and supporting infrastructure.
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Design & Space Planning
Planning and design support for regulated facilities, manufacturing spaces, laboratories, equipment layouts, process flows, and facility improvements.
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Regulatory and quality frameworks that shape the work.
N&CS works within the regulatory and quality frameworks applicable to each client's products, processes, and operations, including FDA requirements, GMP, QMSR, ISO standards, ISPE guidance, EU GMP requirements, and applicable facility, validation, sterilization, and computerized-system standards.