OUR SERVICES
Commissioning & Qualification (C&Q) Services
Computer System VALIDATION(CSV)in GxP environments
Commissioning & Qualification (C&Q) Services
Development and implementation of risk-based C&Q strategies for
Biologics
Sterile Injectables.
Active Pharmaceutical Ingredients (API)
Solid Oral Dosage Forms
Project Management for GxP Projects
Computer System VALIDATION(CSV)in GxP environments
Commissioning & Qualification (C&Q) Services
Enable organizations in delivering complex GxP projects, leveraging industry best practices
Project Management and scheduling adherence for pharmaceutical and biopharmaceutical projects
Computer System VALIDATION(CSV)in GxP environments
Computer System VALIDATION(CSV)in GxP environments
Implementing modern, risk-based approaches to software validation, moving towards Computer System Assurance.
Validation and remediation of computerized systems (GAMP Category 3, 4, & 5).
AUTOMATION Consulting
GxP Compliance & Quality Assurance Consulting
Solution implementation roadmap and execution strategy to transform Manufacturing, Lab, Supply Chain & Quality Management Systems
Strategic Consulting & Roadmap Development
for Technology Selection & Vendor Assessment
GxP Compliance & Quality Assurance Consulting
GxP Compliance & Quality Assurance Consulting
GxP Compliance & Quality Assurance Consulting
Gap assessments and remediation for existing QMS. Development and implementation of robust quality processes. Assessment and improvement of data integrity practices across systems and processes. Mock inspections and readiness assessments