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Output Excellence Through Workflow Effectiveness
Reliable Submissions Solutions
Regulatory Publishing + Submission
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Submission Management (via ESG)
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Regulatory Document Management
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Conversion of Paper To Digital via eCTD Standards
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Submission Validation
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Product Information Management
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Product Lifecycle Management
Regulatory Consulting + Strategy
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Regulatory Affairs Guidance and Recommendations
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U.S. Regulatory Agent Representation
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Clinical Study Report Publishing
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Submission of IND Safety & Adverse Event Reports
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eCTD and Submission Publishing Training
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Project Coordination and Management
Document Formatting + Processing
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Adherence To Document Metadata, Granularity & Convention
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Microsoft Word Style Guides Development & Validation
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Microsoft Word Formatting & Templating Development
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Compliant Adobe PDF Development and Navigation
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Document Adherence To Regulatory and Industry Standards
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Vigorous Document Management Access & Quality Control
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