CMC and eCTD Authoring Automation

eCTD Automation for Module 3 & Annual Reports

Mushroom Solutions provides a unified, end-to-end automation solution for eCTD submissions, enabling life sciences organizations to accelerate CMC development and Annual Reports generation with greater accuracy and compliance. The platform streamlines the creation, management, and publishing of both development Module 3 and commercial Annual Reports by unifying data ingestion, structured CMC modules, Product Feature Documents (PFDs), and collaborative authoring into a single, trusted source of truth.

Built-in automation ensures complete traceability, version control, and audit-ready compliance throughout the submission lifecycle. By eliminating manual handoffs and fragmented documentation, the solution reduces operational effort, minimizes errors, and improves submission quality. Automated workflows support content reuse, controlled updates, and seamless collaboration across regulatory, CMC, and quality teams, enabling faster and more consistent submissions.

The solution is designed to adapt to evolving regulatory requirements while maintaining data integrity and inspection readiness. It supports a wide range of product types, including small molecules, biologics, vaccines, and cell and gene therapies (CGT), making it suitable for both early development and commercial-stage submissions. With scalable architecture and intelligent automation, Mushroom Solutions empowers teams to meet regulatory timelines with confidence and efficiency across global markets.
Bridging Fragmented Workflows
Teams lose time collating data across QMS/LIMS/SharePoint, re-entering values, and reconciling versions. Mushroom automates extraction → structuring → authoring with full traceability—so your eCTD stays consistent from development to commercial lifecycle updates.