Comprehensive GxP compliance auditing for pharmaceuticals, biotech, and medical devices.
Expert guidance on global regulatory requirements and strategic compliance planning.
Design, implementation, and optimization of robust Quality Management Systems.
Full lifecycle validation for equipment, facilities, utilities, and processes.
Ensuring data accuracy and compliance with 21 CFR Part 11 and EU GMP Annex 11.
Simulated inspections to ensure readiness for regulatory agency audits.
Customized training programs to enhance staff competency and compliance awareness.
Proactive risk assessment and management strategies for quality and compliance.
Oversight and auditing of suppliers and third-party vendors to ensure quality standards.
Hands-on support for new facility start-ups and remediation of compliance issues.