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Reliable Submissions Solutions

Regulatory Publishing + Submission

  • Submission Management (via ESG)

  • Regulatory Document Management

  • Conversion of Paper To Digital via eCTD Standards

  • Submission Validation

  • Product Information Management

  • Product Lifecycle Management

Regulatory Consulting + Strategy

  • Regulatory Affairs Guidance and Recommendations

  • U.S. Regulatory Agent Representation

  • Clinical Study Report Publishing

  • Submission of IND Safety & Adverse Event Reports

  • eCTD and Submission Publishing Training

  • Project Coordination and Management

Document Formatting + Processing

  • Adherence To Document Metadata, Granularity & Convention

  • Microsoft Word Style Guides Development & Validation

  • Microsoft Word Formatting & Templating Development

  • Compliant Adobe PDF Development and Navigation

  • Document Adherence To Regulatory and Industry Standards

  • Vigorous Document Management Access & Quality Control

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