GMP Compliance & Audit Readiness

Achieve seamless regulatory compliance and inspection success with our GMP consultancy services tailored for pharmaceutical, biotech, and CRO operations. We guide facilities through cGMP implementation (FDA 21 CFR 210/211, EU GMP Annex 1, WHO standards) and prepare for audits by USFDA, EMA, CDSCO, and ISO 13485 certifications.

We establish robust Quality Management Systems (QMS) covering the 5 pillars: personnel training, facility/equipment validation (IQ/OQ/PQ), documentation control, production/process controls, and laboratory testing. Services include SOP development, risk-based deviation management (CAPA), cleaning validation, and stability programs to ensure product safety, identity, strength, quality, and purity.

Mock audits simulate PAI (Pre-Approval Inspections) and routine GMP inspections, identifying 483 observations and critical gaps in advance. We conduct gap assessments, remediation plans, and training on audit responses, batch record review, and OOS/OOT investigations, achieving zero-warning-letter outcomes.

Comprehensive GMP checklists and readiness scorecards

Validation master plans for equipment, processes, and analytical methods

Internal audit reports with prioritized CAPA timelines

Regulatory submission support integrating GMP data into CTD modules