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mcreddy@catoitpharm.com
Contact Us
+1 (908) 672 3736
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ABOUT US
SERVICES
End to End Regulatory Services
Pharmacovigilence Services
Complaince & Validation Services
Continuous Regulatory Quality Compliance
Documentation and Training Support
Gap Analysis
Method Development
Validation: Process, Cleaning, Equipment, Utilities, Facilities
Computerized Systems Validation
Systems Troubleshooting
Project management
IT Services
REGULATORY SERVICES
Global Market Analysis
Regulatory Consultation and Strategy
Regulatory Assessment and Gap Analysis
Regulatory Pathway Strategy
Regulatory Intelligence
Publishing and Submissions in eCTD
Regulatory Labeling
Artwork and Pack Management
PHARMACOVIGILENCE
Periodic Adverse Drug Experience Reports (PADER)
Periodic Benefit Risk Evaluation Report (PBRER)
ICSR Services
Signal Detection
Literature Monitoring Services
Aggregate Report Services and Periodic Safety report services
IT SERVICES
IT Quality Assurance Works
Guidance in Agile and waterfall methodologies
Identify gaps and support Compliance
Provide solutions for development of applications
CONTACT US
COMPLIANCE AND VALIDATION SERVICES
Continuous Regulatory Quality Compliance
Validation: Process, Cleaning, Equipment, Utilities, Facilities
Documentation and Training Support
Computerized Systems Validation
Systems Troubleshooting
Method Development
Gap Analysis
Project management
