Regulatory Affairs

Regulatory Affairs departments are responsible for capturing, managing and tracking all communications, correspondence, product registrations, submissions and commitments to health authorities. Tracking and managing submissions and follow-up activities for multiple products in countries around the world requires a high degree of organisation and tracking.

Pharmaceutical and biotechnology companies strive to obtain faster time to market and get their products approved as quickly as possible. To do so they need effective management and tracking systems that enable them to manage submissions, track commitments, and obtain current status on outstanding action items. Many companies use rudimentary home grown databases, spreadsheets, or paper-based tracking systems.

TrackWise regulatory affairs solutions

TrackWise is an enterprise quality management software system that creates an efficient, cost-effective, global solution for capturing and tracking all required regulatory submission information, commitments, and tasks pertaining to new products and product lifecycle management.

TrackWise enables your organisation to:

• Improve accuracy of registration information
• Track and manage all phases of the product life cycle and submission process
• Report on registration status by country, product type, indication, dosage, or any other classification
• Manage and track correspondences with health authorities along with resulting commitments and tasks
• Initiate, track and manage changes required to meet regulatory guidelines
• Manage and track regulatory notifications or approvals as a result of change controls initiated by other parts of the organisation
• Manage and track regulatory reporting processes including product safety update reports (PSURs)
• Select one of the applications below to learn more about how TrackWise can help improve your regulatory affairs processes.
• Product life cycles, registration and submission management
• Change control
• Correspondence and commitment tracking
• Product safety update reports (PSURs)