Agatha Regulatory

Agatha Regulatory is a regulatory document management and submission software solution developed by Agatha Corporation for life sciences companies. It provides an all-encompassing platform for the creation, storage, and management of regulatory documents, efficiently compiling submission content even when produced by different teams across multiple locations.

Designed to streamline global regulatory compliance, Agatha Regulatory supports pharmaceutical, medical device, and therapy organisations in managing regulatory activities from early development through to health authority submission. The platform centralises data management, automates key processes, and provides visibility into regulatory activity to help teams lower non-compliance risks and accelerate product development.

Key Benefits

• Streamlined global regulatory compliance: Centralised data management and automated processes provide full visibility into regulatory activity, aligning operations with business objectives and reducing the risk of non-compliance across global markets.
• Accelerated regulatory approvals: Obtaining regulatory authorisation is the most critical step in bringing new drugs, medical devices, and therapies to market. Agatha Regulatory helps streamline and accelerate all regulatory activities and processes, enabling faster patient access to new treatment options and reducing costly delays.
• FDA compliance support: The application enables teams to collect, organise, and manage regulatory documents from all clinical trial sites within regulatory binders prior to submission, establishing a single, authoritative source for all required content.

Main Features and Capabilities

• Submission Viewer: Browse and review submission archives directly within the application using the built-in submission viewer.
• eCTD Integration: Out-of-the-box integration with most eCTD submission software products, enabling seamless electronic Common Technical Document workflows.
• Application and Correspondence Tracking: Track regulatory applications and health authority correspondence throughout the submission lifecycle.

Agatha Regulatory is purpose-built for life sciences organisations seeking to manage regulatory binders, coordinate multi-site clinical trial documentation, and maintain compliance with global health authority requirements. The platform is available with multilingual support and can be explored via a product demo through Agatha Corporation's contact channels.