- Office-hours : 9:00 AM to 5:00 PM USA CST
GxP Solutions provides inspection-focused GxP consulting services designed for organizations that require credible regulatory expertise and hands-on execution.
Unlike large consulting networks or staffing-based models, our services are delivered with direct senior involvement and grounded in real FDA inspection experience.
We conduct independent, risk-based GxP audits aligned with FDA, EMA, and ICH expectations. Our audits assess system effectiveness, inspection risk, and regulatory compliance, not just procedural adherence.
GMP, GCP, GVP, GLP, GDP & CSV audits
Internal Quality System audits
Vendor, supplier & CRO audits
Clinical site audits
Pharmacovigilance system audits
Mock FDA inspections
Our inspection readiness services help organizations prepare for FDA and global regulatory inspections by replicating FDA inspection flow, questioning techniques, and enforcement focus areas.
Led by a former FDA Investigator, our mock inspections identify vulnerabilities before regulators do.
FDA mock inspections
Inspection readiness gap assessments
FDA 483 response support
Warning Letter remediation strategy
Inspection coaching for executives and SMEs
We design, remediate, and optimize GxP Quality Management Systems (QMS) to ensure compliance, sustainability, and inspection readiness.
Our remediation strategies address systemic root causes, helping prevent repeat observations and enforcement escalation.
CAPA system effectiveness
SOP development and remediation
Deviation and change control programs
Data integrity and CSV compliance
Quality Agreements and vendor lifecycle management
