Our solutions ensure that all GxP-regulated systems, equipment, and facilities
perform reliably and meet international regulatory requirements including FDA,
EU GMP, WHO, and PIC/S guidelines.
Our Quality Services Cover:
Quality Management System (QMS) Implementation:
Development of QMS aligned with ICH Q10 and ISO standards
SOP creation, review, and lifecycle management
Change control, deviation, and CAPA systems
Document control and version tracking
Audit Readiness & Compliance Consulting:
Internal audits and mock inspections
Regulatory gap assessments (FDA, WHO, CDSCO, MHRA)
Support for audit response (483s, warning letters)
Preparation of remediation plans and timelines
GxP Compliance Support:
GMP, GLP, GDP, and GCP consulting
Review of manufacturing records, QC documents, and batch records
Qualification of suppliers, systems, and service providers
Data Integrity assessments aligned with ALCOA+ principles
Training & Awareness Programs:
GxP training for production, QA, QC, IT, and management teams
SOP training and documentation best practices
Data integrity, audit readiness, and compliance workshops
Custom training modules for CSV, QMS, and regulatory topics
