Regulatory

Agatha's regulatory submission software is designed to streamline the management of regulatory documents for life science companies. It offers a comprehensive solution for compiling submission content, even when created by different teams across various locations.

The software facilitates global regulatory compliance by providing centralized data management, automating processes, and offering visibility into regulatory activities. This alignment with business objectives helps manage global operations more effectively, reduces non-compliance risks, and accelerates product development.

Accelerating regulatory approval is crucial for bringing new drugs, medical devices, and therapies to market. The software serves as an eRegulatory solution to streamline and expedite all regulatory activities and processes, ensuring faster patient access to new options and minimizing costly delays.

For FDA compliance, the software collects, organizes, and manages regulatory documents from all clinical trial sites into regulatory binders before submission, serving as a single authoritative source for all required content.

Main Features

• View Submissions: Browse submission archives using the submission viewer.
• eCTD Integration: Out-of-the-box integration with most eCTD submission software products.
• Track Applications: Monitor regulatory applications and health authority correspondence.