Ensuring GMP, GCP, GLP, CSV, Data Integrity & Digital Validation Excellence
Audit-ready. Risk-based. Globally compliant.
Delivering audit-ready, risk-based compliance solutions that meet global regulatory standards
Deep knowledge of FDA, EMA, and global GxP requirements
Documentation that withstands the most rigorous audits
Pragmatic approaches aligned with GAMP 5 and ICH Q9
Compliance across FDA, EMA, WHO, PIC/S, and ISO frameworks
Comprehensive compliance solutions tailored to your regulatory needs
Strategic guidance for GMP, GCP, and GLP implementation
Computer System Validation and Computer Software Assurance
ALCOA+ principles and Part 11 compliance
Quality Management System implementation and optimization
Cloud, AI, RPA, and digital transformation validation
Preparation, defense, and CAPA management
Comprehensive coverage of global regulatory frameworks
FDA
EMA
ISPE
ISO
ICH
WHO / PIC/S
A systematic methodology that ensures regulatory success
Gap analysis and risk assessment
Validation strategy and planning
Execution with quality controls
Audit support and remediation
Ongoing compliance maintenance
Specialized compliance solutions across the life sciences spectrum
Drug manufacturing compliance
Biologics and biosimilars
Device validation and QMS
Clinical trial compliance
Software as Medical Device
Get expert guidance to ensure compliance and avoid costly findings.