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The Role of Regulatory Tracking Software in Accelerating Drug Approval Processes

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  1. manages product dossiers including regulatory product information,
  2. aids in the preparation of product submissions in regulated formats, and
  3. manage the submission of information in approved formats to regulatory agencies.
  1. Provides clear oversight of original and lifecycle submissions
  2. Provides appropriate support for the firm’s size and complexity
  3. Helps to stay ahead of the game and remain compliant with the comprehensive regulatory tracker for the pharmaceutical industry
  4. Tracks statutory and regulatory changes across global countries and compile their findings into an easy-to-use resource
  5. Minimizes effort and calendar time to replicate regulatory submission between products and regulatory agencies
  6. Helps in streamlining regulatory compliance for smoother operations
  7. Helps to easily meet upcoming national regulations on serialization of drugs to ensure patient safety
  8. This tracker provides an editorially curated resource for attorneys representing drug companies who need to monitor regulatory activity affecting their clients. In addition to summarizing regulatory activity, this tracker features action items for attorneys including effective dates and compliance dates, deadlines for submitting comments in response to proposed rules and draft guidance, and other key information