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Assyro

Business

Assyro AI is the regulatory copilot for pharma and biotech - combining submission drafting, eCTD/RPS validation, regulatory intelligence

About Assyro

Assyro is an AI-powered platform designed for regulatory, quality, and submission teams in the pharmaceutical, biotech, and medical device sectors. It streamlines the preparation and validation of regulatory documentation, offering features such as real-time eCTD validation, collaborative drafting, and audit-ready workflows. The platform integrates with document management systems like SharePoint, Box, and Google Drive to keep source documents synchronized and reduce handoff errors. Pricing is customized based on workflow and rollout scope, with unlimited users included in every plan. Assyro is intended to help teams reduce rework, accelerate submission cycles, and maintain compliance across jurisdictions.

Best for: regulatory affairs teams, pharmaceutical companies, biotech companies, medical device companies, regulatory consultants

Key features

  • Provides a collaborative workspace for drafting and validating regulatory submissions
  • Integrates with SharePoint, Box, and Google Drive to sync source documents
  • Offers real-time tracking of submission readiness and validation findings
  • Automates deadline-driven workflows for validation and readiness checks
  • Supports audit-ready workflows aligned with regulatory standards
  • Allows scaling of submission capacity without increasing headcount

Use cases

  • Drafting and validating regulatory submissions for FDA and other agencies
  • Coordinating submission workflows across multiple jurisdictions
  • Maintaining audit-ready documentation and compliance trails

Pros

  • Unlimited users included in every plan
  • Custom pricing tailored to workflow and rollout needs
  • Pilot-first approach allows starting with a single workflow

Limitations

  • Custom pricing requires a call to receive a proposal

Screenshots

Assyro screenshot

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