We provide global Quality and Compliance consulting services to develop programs and compliance processes that promote continuous improvements to productivity and quality. 

Includes

• Phase-appropriate Quality Management System (eQMS) creation 
• Policies and Procedures development
• Change controls, CAPA, deviations, OOS/OOT
• QP Release
• Stability Studies
• Record retention per cGxP requirements
• GxP Training
• Quality Assurance support for critical utilities, equipment and facilities
• Tech transfer from R&D to commercial
• GMP Process validation and method qualification
• Site validation master plan
• Cleaning validation and critical utilities
• IQ, OQ, PQ Validation Executions
• Supplier qualification programs