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Regulatory Information Management

ClinChoice manages global regulatory information with expert technology prowess, a deep understanding of global and local regulations, and the best data management practices

ClinChoice applies its expertise in regulatory affairs and technology to help organizations manage their regulatory data. Our consultants provide general data maintenance support in Regulatory Information Management System (RIMS) software to deliver solutions that will ensure application submission, approval, renewals on time, improve operational process efficiency and tracking. We provide the required support in management and control of the drug registration process, which helps the drug and medical device manufacturing companies to have:

  • Visibility and tracking of all regulatory information
  • Timely submissions of the application by affiliates
  • Timely responses to questions
  • Instant access to all regulatory information and documents quality and compliance

 

With our help, organizations can develop short- and long-term strategies to meet submission timelines with minimal impact on day-to-day operations. We add value by improving data capture and submission processes while enabling sponsors to adapt to changes in regulations quickly.

 

Our application management services include:

  • Screen customization
  • Configuration management
  • Product validation
  • Custom reports
  • Third-party application management
  • Dictionary management
  • Database management
  • Application server management
  • Application administration

 

Our data management services include:

  • Request Analysis from local affiliates for record creation or updates
  • Review of supporting documents for record creation or updates
  • Data clean-up and maintenance at drug and registration level
  • Ad-hoc and bulk license record changes from local affiliates or sponsors
  • Fill in the required data in the software fields at the Drug Product and Registration level
  • Maintain the Variations, Questions, and Commitments
  • Updating local market registration data
    • Local product name
    • MAH
    • License details
    • Formulation
    • Packaging
    • Manufacturing Sites
    • Application Submission
    • Approval
    • Marketing Launched
    • Renewal and Withdrawn status and status dates
  • Create the query to retrieve data output for customers’ requirements and generate report outputs to meet the business needs.
  • Maintenance of additional data required for xEVMPD in EEA countries
  • Perform xEVMPD data submission manually in EVWEB for scenarios not supported by RIMS
  • Address queries from local and global teams
  • Provide process and module-based training/workshops

 

Our technical team’s expertise includes:

  • Installation qualification
  • Operational qualification
  • IQ and OQ execution
  • Validation summary reports