Regulatory Submission

Simploud's Regulatory Submission module is a centralized platform designed to help life sciences companies manage product registrations, variations, and renewals across global and local markets. It is built for organizations in pharmaceutical, biotechnology, medical device, digital health, medical cannabis, and other life sciences industries that must comply with regulatory authority requirements before selling products in specific markets.

Regulatory authorities require registration of all medical products intended for human use or consumption, and in many cases — such as pharmaceutical and biologic products — each marketed dosage and package must be individually registered and approved. Simploud automates this process at both global and regional levels, improving overall processing time for regulatory activities and ultimately delivering a better time-to-market.

Core Registration Management Capabilities

• Centralized management of product registrations, variations, and renewals in a single platform
• Support for gaining approval to sell new products, renew licenses for existing products, and manage every product-related change requiring regulatory approval
• Tracking of product registration status across different countries, providing valuable insight into where products are sold and their current approval status
• Assistance with answering regulatory queries, adverse event reporting, and managing product-related changes

Automation and Timeline Management

• Automated calculation of regulatory timelines based on different country-specific rules
• Intelligent initiation of reminders and actions based on calculated schedules
• Proactive driving of all submission activities forward to increase the efficiency of regulatory work
• Dynamic workflows available to support individual country or region-specific workflow requirements

Registration Tracking Dashboard

• Drag-and-drop reporting and dashboard tools providing up-to-date status information on product registrations
• Real-time visibility into exactly where each submission stands in each country
• Global view of potential delays and resource conflicts for users and management
• Improved transparency across the organization enabling faster, more informed decision-making at lower cost
• Comprehensive visibility into all aspects of global product status, enabling quick impact analysis of every change
• Automated triggering of all required actions resulting from product or regulatory changes

The Simploud platform is described as secured, scalable, and compliant, making it suitable for regulated life sciences environments. It serves a broad range of industries including biotechnology, pharmaceutical, medical device, CDMO/CMO/CRO, laboratory and imaging, and universities, among others.