Our Services
Our on-site GMP audits deliver a comprehensive, risk-based evaluation of quality systems, production and maintenance controls, laboratory controls, and documentation against FDA 21 CFR and ICH regulations.
We emphasize focus on how procedures are actually executed, identifying compliance gaps, systemic risks, and opportunities to strengthen inspection readiness and operational performance.
Our experts routinely audit against 21 CFR Part 210, 211, 312, 314, 600, 801, 820, USP Monographs/General Chapters, ICH, and other applicable governing bodies.
GMP Auditing
We support the investigation, remediation, and closure of nonconformances and CAPAs through instructor-led courses in in-depth RCA and problem-solving processes. We’re also available to augment your site’s investigator resources to help relieve backlogged, aged, or more-complex investigations.
We help organizations identify true root causes, assess product and patient risk, and implement corrective and preventative actions that are practical and effective.
Our approach emphasizes scientific rationale, system-level corrections, and outcomes that are defensible to regulatory bodies.
CAPA/Nonconformance Program Refinement
Risk Management Assessments
We provide ICH Q9-aligned quality risk management assessments that evaluate how risks to product quality and patient safety are identified, assessed, controlled, and reviewed across manufacturing and quality systems.
Our risk management services include the development and facilitation of process-focused risk assessments, including Process Failure Modes and Effects Analysis (pFMEA), applied in accordance with ICH Q9 principles.
Our approach focuses on practical application of risk management principles and integration into day-to-day GMP operations that withstand regulatory scrutiny and inspection challenge.
Operational Excellence and Continuous Improvement
We support operational excellence and continuous improvement initiatives using proven methodologies such as DMAIC, time studies/cycle time reduction, Kaizen, and Gemba-based assessments that strengthen GMP compliance while improving reliability, efficiency, and execution.
We work with manufacturing and quality teams to identify performance gaps, reduce variability, and embed practical improvement practices that are sustainable and inspection ready.
What We Do Best
Core Good Manufacturing Practices (GMP)
Quality Management System (QMS) design, assessment, and remediation
Form Fill Seal (FFS) Manufacturing
Sterile and Aseptic Manufacturing
CDMO/CMO - Contract Manufacturing
Sterility Assurance and Microbiological Control Strategies
Container Closure Integrity (CCI)
Batch Record Design and Execution Review
FDA cGMP Compliance (21 CFR 210, 211, and 820)
Data Integrity - ALCOA+
Investigations and CAPA
FDA 483 and Warning Letter Remediation Support
Nonconformance/Deviations Investigations
Root Cause Analysis (RCA) methodologies
CAPA Strategy Development and Effectiveness Checks
Quality Risk Management
Risk Management Lifecycle Review and Risk Governance
Process Failure Modes and Effects Analysis (pFMEA)
Sampling Plan Development and Optimization
Integration of Risk Management into CAPA, Nonconformances, and Change Control Processes
Environmental Monitoring Program Design and Assessment
Equipment/Process Qualification (IQ/OQ/PQ)
Continued Process Verification (CPV) and Statistical Process Control (SPC)
Operational Excellence
DMAIC-based Problem Solving in GMP Environments
Time Studies/Cycle Time Reduction (CTR) Process Optimization
Kaizen-Integrated Change Control Strategies
Gemba-Based Process Assessments
Standard Work and Procedural Effectiveness
Process Centerlining