Authorization
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Wide range of templates, formatting tools, and collaboration features.
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Enhanced document management with version control, tracking, and reporting.
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Supports multiple authoring workflows and roles for efficient collaboration.
Validation
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Advanced validation rules and checks for compliance with ICH and regional guidelines.
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Automated validation process with reporting and audit trails.
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Integration with quality management systems (QMS) for comprehensive quality control.
Submission
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Supports submissions to many regulatory agencies globally.
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Electronic submission capabilities in various formats.
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Tracking and reporting tools for submission status and regulatory interactions.
Integration
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Micro-Service based architecture for Seamless integration with other applications for data exchange and process streamlining
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Integration with DMS for centralized document storage.
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API-based integration with third-party systems for data exchange and workflow automation.
Regulatory Intelligence
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Chat-GPT and LLM integrated with comprehensive regulatory knowledge base for guidance, and agency-specific requirements.
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Regulatory updates and alerts to keep users informed of changes.
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Regulatory support services from our experts and GPT enabled assistance for complex submissions and compliance challenges.