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ICSR management, being the most scientific and priory activities, needs multiple platforms trained team. COD provides complete ICSR management services via in-house/client hosting system.
As case processing is dynamic and resource driven, we do consider supporting client on all the following aspects:
Case Intake and Processing Services
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Scheduling
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Authoring
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SME Review
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Submission
Specialized Aggregate Reports Services
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Submission of RFI and PRAC assessment Report
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Line listings Review
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Regulatory Website review & tracking of PSUR report
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Publishing of Report
MAH System Support
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GAP Analysis/Audit
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Oversight System Setup
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Workshop/Training
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