Regulatory Affairs & Compliance Directives

• Process, Finishing, Laboratory, Equipment verification & validation programs
• cGMP/cGLP, QSR, GAMP, 13485 for Medical Devices, ISO9000, ISO-Guide 25, policies & procedures development, implementation and transitioning
• FDA client representation and liaison
• Consent decree remediation initiatives
• Inspection, auditing, corrective action planning/implementation for vendors, production, laboratories and manufacturing-related areas
• 21CFR Part 11 strategic compliance initiatives and implementation
• Computer systems qualification, verification & validation programs