# Assyro AI

> Assyro is an AI regulatory submission workspace for pharma, biotech, medical device, CRO, CDMO, regulatory consulting, and regulated quality teams. The platform combines regulatory writing, eCTD and eSTAR authoring, continuous validation, regulatory intelligence, lifecycle management, and audit-ready submission execution.

Assyro helps life sciences teams plan, draft, review, validate, and maintain regulated submissions in one workspace. It is built for teams working on FDA-centered programs today, with global regulatory intelligence and multi-jurisdiction workflow support across FDA, EMA, ICH, Health Canada, and PMDA contexts.

Use this file as a concise map of Assyro's public site. It is intended to help AI agents understand the platform, route users to the right canonical page, and avoid unnecessary crawling.

Primary use cases:
- Draft regulatory documents with AI assistance, linked citations, tracked changes, and human review ownership.
- Validate eCTD sequences against ICH and FDA technical requirements before submission lock.
- Author and validate FDA eSTAR, 510(k), and De Novo medical device packages.
- Monitor regulatory guidance, FDA letters, CFR/USC references, and regulatory updates.
- Manage submission lifecycle work across IND, NDA, BLA, ANDA, 510(k), and De Novo programs.
- Coordinate Regulatory Affairs, Regulatory Operations, Regulatory Publishing, CMC, Medical Affairs, and Quality teams.

## Primary Pages

- [Homepage](https://assyro.com/): Overview of Assyro's AI regulatory submission workspace.
- [Platform](https://assyro.com/platform): All platform capabilities for submission-ready execution.
- [Solutions](https://assyro.com/solutions): Industry-specific workflows for pharma, biotech, medical devices, CROs, CDMOs, and consultants.
- [Submissions](https://assyro.com/submissions): Submission workflow templates by filing type.
- [Teams](https://assyro.com/teams): Team-specific operating templates.
- [Tools](https://assyro.com/tools): Free public regulatory tools.
- [Resources](https://assyro.com/resources): Regulatory references, glossary, guides, and analysis.
- [Pricing](https://assyro.com/pricing): Platform pricing and plan information.
- [Contact](https://assyro.com/contact): Book a demo or request information.

## Platform Capabilities

- [Regulatory Intelligence](https://assyro.com/platform/regulatory-intelligence): Monitor FDA, EMA, ICH, Health Canada, and PMDA updates and map changes to affected programs, documents, owners, and timelines.
- [Regulatory Writing](https://assyro.com/platform/regulatory-writing): Draft submission content with linked citations, reusable language, tracked review, and audit history.
- [Medical Writing](https://assyro.com/platform/medical-writing): Prepare clinical study reports, patient narratives, investigator brochures, and Module 2.5/2.7 clinical summaries.
- [eCTD Software](https://assyro.com/platform/ectd-software): End-to-end eCTD authoring, validation, publishing, viewing, templates, and lifecycle controls.
- [eCTD Viewer](https://assyro.com/platform/ectd-viewer): Inspect eCTD sequences, modules, leaves, metadata, and lifecycle operations.
- [eCTD Templates](https://assyro.com/platform/ectd-templates): Controlled CTD module templates, reusable language, and review routing.
- [eCTD Authoring](https://assyro.com/platform/ectd-authoring): Draft content directly against controlled CTD structure.
- [eCTD Publishing](https://assyro.com/platform/ectd-publishing): Assemble submission-ready eCTD sequences with source-to-submission traceability and lifecycle operations.
- [eCTD Validation](https://assyro.com/platform/ectd-validation): Run continuous structural, lifecycle, metadata, and technical conformance checks.
- [Predicate Intelligence](https://assyro.com/platform/predicate-intelligence): Compare FDA predicates and substantial-equivalence evidence for medical device strategy.
- [eSTAR Authoring](https://assyro.com/platform/estar-authoring): Author FDA 510(k) and De Novo eSTAR-ready submission packages.
- [eSTAR Validation](https://assyro.com/platform/estar-validation): Check eSTAR completeness and Refuse-to-Accept risks before submission.
- [Lifecycle Management](https://assyro.com/platform/lifecycle-management): Manage amendments, supplements, annual reports, variations, and sequence history.
- [Gap Analysis](https://assyro.com/platform/gap-analysis): Identify missing or weak submission content and prioritize remediation.

## Submission Workflows

- [IND Submission Software](https://assyro.com/submissions/ind): Investigational New Drug workflows for study-start readiness, clinical hold response planning, and Module 1-3 coordination.
- [NDA Submission Software](https://assyro.com/submissions/nda): New Drug Application workflows for filing readiness, supplement tracking, and PDUFA execution.
- [BLA Submission Software](https://assyro.com/submissions/bla): Biologics License Application workflows for CMC dependencies, evidence coordination, and review readiness.
- [ANDA Submission Software](https://assyro.com/submissions/anda): Abbreviated New Drug Application workflows for generic drug filing execution.
- [510(k) Submission Software](https://assyro.com/submissions/510k): Premarket Notification workflows for predicate strategy, substantial equivalence, and eSTAR packaging.
- [De Novo Submission Software](https://assyro.com/submissions/de-novo): De Novo workflows for novel device classification, evidence gaps, and FDA review readiness.

## Solutions By Industry

- [Pharma](https://assyro.com/solutions/pharma): NDA, BLA, IND, ANDA, supplement, and lifecycle workflows for pharmaceutical companies.
- [Biotech](https://assyro.com/solutions/biotech): Lean IND-through-BLA execution for emerging biotechnology teams.
- [Medical Devices](https://assyro.com/solutions/medical-devices): 510(k), De Novo, predicate, evidence, eSTAR, and PMA-adjacent workflows.
- [CROs](https://assyro.com/solutions/cro): Multi-sponsor submission delivery with controlled workspaces and client visibility.
- [CDMOs](https://assyro.com/solutions/cdmo): Sponsor-facing Module 3 CMC documentation and manufacturing change workflows.
- [Regulatory Consultants](https://assyro.com/solutions/consultants): Multi-client submission management for regulatory consulting firms.

## Team Workflows

- [Regulatory Affairs](https://assyro.com/teams/regulatory-affairs): Strategy, agency interaction, submission planning, validation, and filing execution.
- [Medical Affairs](https://assyro.com/teams/medical-affairs): Medical and clinical writing workflows with evidence traceability and RA review.
- [Regulatory Operations](https://assyro.com/teams/regulatory-operations): Milestones, publishing mechanics, validation triggers, gateway workflows, and portfolio readiness.
- [Regulatory Publishing](https://assyro.com/teams/regulatory-publishing): eCTD assembly, lifecycle operations, validation, and handoff quality.
- [CMC](https://assyro.com/teams/cmc): Module 3 authoring, ICH Q1-Q14 aligned templates, stability, specifications, comparability, and CDMO coordination.
- [Quality](https://assyro.com/teams/quality): GxP, Part 11, Annex 11, CAPA, audit trail, inspection readiness, and quality review workflows.

## Free Regulatory Tools

- [eCTD Validator](https://assyro.com/tools/ectd-validator): Browser-based eCTD structural validation with no account required.
- [ROI Calculator](https://assyro.com/tools/roi-calculator): Estimate the cost of review cycles, validation rework, and regulatory coordination overhead.
- [PDUFA Calendar](https://assyro.com/tools/pdufa-calendar): Track FDA PDUFA dates, review milestones, sponsors, products, therapeutic areas, and outcomes.
- [FDA Purple Book Tool](https://assyro.com/tools/fda-purple-book): Search FDA Purple Book data for biologics, biosimilars, reference products, exclusivity, and patents.
- [FDA Inspection Database](https://assyro.com/tools/fda-inspection-database): Search FDA final-action inspections, citations, firms, FEI numbers, classifications, and 483 records.
- [FDA 483 Database](https://assyro.com/tools/fda-483-database): Search published FDA Form 483 inspection observations.
- [FDA Inspection Citations](https://assyro.com/tools/fda-inspection-citations): Explore CFR-linked inspection citation patterns.
- [Regulatory Alerts](https://assyro.com/tools/regulatory-alerts): Monitor FDA, ICH, EMA, Health Canada, and PMDA regulatory changes.

## Regulatory Intelligence And Data

- [Regulatory Intelligence Hub](https://assyro.com/regulatory-intelligence): Top-level hub for regulatory monitoring, references, notes, and search.
- [US Regulatory Intelligence](https://assyro.com/regulatory-intelligence/us): US-focused regulatory sources and workflows.
- [21 CFR Title 21 Explorer](https://assyro.com/regulatory-intelligence/us/cfr/title-21): Electronic Code of Federal Regulations navigation for FDA-related rules.
- [21 USC Title 21 Explorer](https://assyro.com/regulatory-intelligence/us/usc/title-21): United States Code food and drug law references.
- [FDA Letters Monitor](https://assyro.com/regulatory-intelligence/us/letters): FDA warning letters, untitled letters, closeout letters, complete response letters, and related categories.
- [Regulatory Updates](https://assyro.com/regulatory-intelligence/updates): Recent regulatory publications and update monitoring.
- [Regulatory Search](https://assyro.com/regulatory-intelligence/search): Full-text search across regulatory content.
- [Regulatory Authorities](https://assyro.com/regulatory-intelligence/authorities): Authority-level reference pages.
- [Jurisdiction Comparison](https://assyro.com/regulatory-intelligence/compare): Compare regulatory expectations across jurisdictions.
- [Regulatory Notes](https://assyro.com/regulatory-intelligence/notes): Interpretive notes and supporting context mapped to regulatory sources.

## Glossary And Resources

- [Regulatory Glossary](https://assyro.com/glossary): Canonical definitions of regulatory terms across submissions, clinical, CMC, pharmacovigilance, quality, and medical devices.
- [eCTD](https://assyro.com/glossary/ectd)
- [CTD](https://assyro.com/glossary/ctd)
- [IND](https://assyro.com/glossary/ind)
- [NDA](https://assyro.com/glossary/nda)
- [BLA](https://assyro.com/glossary/bla)
- [ANDA](https://assyro.com/glossary/anda)
- [510(k)](https://assyro.com/glossary/510k)
- [De Novo](https://assyro.com/glossary/de-novo)
- [PDUFA](https://assyro.com/glossary/pdufa)
- [Complete Response Letter](https://assyro.com/glossary/complete-response-letter)
- [FDA Warning Letter](https://assyro.com/glossary/warning-letter)
- [CMC](https://assyro.com/glossary/cmc)
- [GMP](https://assyro.com/glossary/gmp)
- [GCP](https://assyro.com/glossary/gcp)
- [ICH](https://assyro.com/glossary/ich)
- [21 CFR Part 11](https://assyro.com/glossary/21-cfr-part-11)
- [Blog](https://assyro.com/blog): Regulatory submission and industry articles.
- [Insights](https://assyro.com/insights): Analysis on regulatory operations, AI, and submission workflows.
- [News](https://assyro.com/news): Company and product news.
- [Newsletter](https://assyro.com/newsletter): Regulatory intelligence newsletter.
- [Compliance Dossier](https://assyro.com/compliance): Compliance posture and supporting material.
- [Security](https://assyro.com/security): Security controls and regulated-workflow posture.

## Company And Policies

- [Pricing](https://assyro.com/pricing): Platform pricing.
- [Contact](https://assyro.com/contact): Demo and sales contact.
- [Privacy Policy](https://assyro.com/privacy-policy)
- [Terms of Use](https://assyro.com/terms-of-use)
- [Legal](https://assyro.com/legal)
- [LinkedIn](https://linkedin.com/company/assyro)