Solutions

Services:

Program and Project Management
Quality Management Systems
Cleaning Validation and Sterilization
Validation Process Optimization
Computer System Validation
(CMO)Contract Manufacturer Organization Third Party Selection Services
(GxP)Quality Systems Audits and Gap Analysis
Product Security: Serialization Track and Trace
Technology Transfer
Technical Writing: APR(Annual Product Reviews), Health Authority audit response, SOPs, Validation Protocols and Reports
Quality Assurance: Deviations, OOE/OOS, CAPA, Change Management, Interim controls and remediation