GxP Documentation
Validation planning, requirements, execution records, release and closing across the full document lifecycle.
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N&CS Consulting Group partners with pharmaceutical, biotech and medical-device companies to close compliance gaps, validate critical systems, and stand up to the toughest regulatory scrutiny.
Founded in Puerto Rico in 2010, N&CS Consulting Group helps life-science companies achieve GMP compliance and process excellence. We reduce non-conformances, regulation violations and compliance gaps — the issues that lead to complaints, recalls, warning letters and lost credibility.
Validation, manufacturing management and capital project management (PMO).
Senior consultants lead every engagement, supported by trained specialists.
End-to-end GxP support across the validation lifecycle — from documentation and planning through execution, release and closure.
Validation planning, requirements, execution records, release and closing across the full document lifecycle.
Learn more →Process, cleaning, equipment, computerized-system and sterilization validation, plus commissioning of facilities and utilities.
Learn more →Remediation for FDA 483 observations and consent decrees, CAPA, complaint investigations and audit readiness.
Learn more →Capital project and manufacturing management for jobs from $3K to $10MM, delivered on schedule and in compliance.
Learn more →Manufacturing engineering, instrumentation and calibration, monitoring studies and equipment support.
Learn more →Low-cost supervised talent for FDA-regulated clients — mentored graduate resources at a promotional rate.
Learn more →Our staff interfaces routinely with regulatory agencies and committees, leading seminars and training to stay ahead of new requirements.
Finished pharmaceuticals, solid dosage and sterile manufacturing.
Biopharmaceutical processes and active pharmaceutical ingredients.
Part 820 QSR, design controls and device qualification.
FDA, EMA/EMEA and international standards experience.
"Driven by Quality" is our company motto and our first priority in every business decision, plan and execution.
Excellence measured against the toughest industry benchmarks, on every task.
A 90% retention rate and industry-competitive salaries keep senior expertise on your project.
Trained on 21 CFR Part 11/211/820, ISPE, ISO and EMEA — and constantly updated.
Certification #PR02088 — a qualified diverse supplier for your programs.
Tell us about your validation, remediation or project-management needs and we'll assemble the right team.
N&CS embedded senior validation expertise into our line and turned around our 483 remediation ahead of schedule.
Their documentation discipline is exactly what an FDA audit demands. Nothing left to chance.
The team's regulatory knowledge and mentorship model gave us capacity without sacrificing quality.
Representative engagement outcomes. Client names available on request under NDA.