Agatha for Biotech

Accelerating Early-Stage Clinical Development

Biotech companies often operate with lean teams and need to maximize efficiency in their clinical development processes. Agatha provides an intuitive, cloud-based document management system that simplifies the organization, review, and approval of essential clinical and regulatory documents, reducing administrative burden and speeding up trial execution.

Simplifying Regulatory Submissions

Navigating the complex regulatory landscape is a significant challenge for biotech firms. Agatha streamlines the regulatory submission process by offering a pre-configured CTD (Common Technical Document) structure. This enables biotech companies to efficiently prepare and manage submission documents in a secure, centralized environment, ensuring compliance with evolving regulatory requirements.

Enhancing Collaboration Across Research Teams

Biotech companies frequently collaborate with CROs, academic institutions, and external partners. Agatha facilitates seamless document sharing and collaboration, ensuring that all stakeholders have real-time access to up-to-date information while maintaining security and compliance.

Ensuring Compliance with GxP and Quality Standards

Compliance with GxP regulations and quality standards is critical for biotech companies. Agatha simplifies SOP management by providing automated workflows for SOP creation, review, approval, and tracking. It also ensures compliance with Part 11 and QMS requirements, helping biotech firms maintain high-quality standards.

Reducing the Administrative Burden of Clinical and Quality Management

Biotech teams need to focus on innovation, not paperwork. Agatha automates document workflows, version control, and compliance tracking, reducing manual workload and improving efficiency in clinical trial operations and quality management.

Supporting Global Expansion with Multilingual eTMF Capabilities

As biotech companies expand their clinical trials across multiple countries, Agatha’s multilingual eTMF solution ensures seamless collaboration and regulatory alignment on a global scale. By centralizing trial documentation, Agatha helps biotech firms manage cross-border compliance and streamline multinational trial operations.