Regulatory Affairs for Pharma & Biotech

Managing Regulatory Compliance

The Sparta regulatory compliance management solution meets the needs of regulatory affairs professionals responsible for all communications and correspondence required by the health authorities. It provides a centralized repository to manage global product portfolios, delivering an efficient, cost-effective way to manage regulatory tasks pertaining to new products and product lifecycle management.

It integrates with other systems and provies real-time data on a global scale. It helps streamline RA workflows and improves time-to-market by providing users with tracking tools that replace time consuming and error-prone excel spreadsheets and other manual tracking processes.


Benefits of Sparta's Regulatory Compliance Software Solution

  • Provides a closed-loop between change control and regulatory submissions.
  • Manages regulatory tracking and all phases of the regulatory compliance process, product life cycle, and submission process.
  • Facilitates global compliance by reporting on registration status by country, product type, indication, dosage or any other classification.
  • Integrates with document and change management, SOP tracking, Clinical Trial Document (CTD), and regulatory auditing.
  • Manages and tracks correspondences with health authorities along with resulting commitments and tasks.
  • Manages and tracks regulatory notifications or approvals as a result of change controls initiated by other parts of the organization.
  • Manages and tracks regulatory reporting processes including product safety update reports (PSURs), with links to original submissions.
  • Ensures faster response time to resolve findings or warning letter issues.
  • Provides real-time access to relevant health authority correspondence and commitment information to all the individuals involved in answering commitments.
  • Provides access to source regulatory correspondence documents by integrating with a document management system.
  • Increases speed and accuracy of commitments responses.
  • Eliminates redundant systems and reduces repetitive and manual data entry.
  • Improves control and consistency in the commitment management process.
  • Reduces errors and decreases repeat inquiries from health authorities.

Regulatory Affairs Processes

Capture, manage, and track all communications, correspondence, product registrations, submissions, and commitments to health authorities. 

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