ONE PLATFORM FOR
REGULATORY SUBMISSION MANAGEMENT
Hyrding brings document management, collaboration, AI-assisted authoring, and compliance tracking into a single platform built for life sciences teams.​
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Regulatory submissions are complex, high-stakes projects involving dozens of contributors, hundreds of sections, and constant deadlines. Hyrding helps teams manage the entire process — from first draft through final submission — with structured workflows, real-time visibility, and built-in compliance controls.
STRUCTURED DOCUMENT MANAGEMENT
Built for Submission-Ready Documentation
Hyrding replaces scattered folders, email chains, and disconnected review cycles with a structured system designed around regulatory submissions. Documents are organized to match submission frameworks, with clear ownership, version control, and real-time tracking across every section.
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FEATURE HIGHLIGHTS:
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Incorporate your own templates aligned to ICH, FDA, and EMA standards
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Section-level ownership and accountability
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Centralized repository with version control
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Real-time document and section status tracking
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Metadata tagging and cross-referencing
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Microsoft Word integration via the Hyrding Add-in
AI-ASSISTED AUTHORING
Draft Faster Without Sacrificing Quality
Use AI to accelerate drafting, maintain consistency, and reduce manual work.
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Hyrding’s AI tools help teams generate structured content, surface inconsistencies, and streamline repetitive authoring tasks — all within Microsoft Word. Your experts stay in control while AI speeds up the process.
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CAPABILITIES:
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AI-generated content
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Source data ingestion from TFLs and prior submissions
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Cross-document consistency checks
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Regulatory language suggestions
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Integrated scientific research assistance
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One-click content refinement and plain-language review
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Unlike general-purpose AI tools, Hyrding AI is grounded in your source data and regulatory standards.
WORKFLOW COLLABORATION
Keep Teams Aligned and Timelines Moving
Give every contributor visibility into what’s assigned, in review, and at risk.
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Submission delays often come from disconnected workflows and unclear handoffs. Hyrding makes responsibilities, approvals, and deadlines visible across the entire project so teams can identify blockers early and keep work moving.
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The Shepherd App gives document managers oversight across active submissions, while the User App provides contributors with a focused workspace for drafting, reviewing, and approvals.
Shepherd App Features
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Project-wide progress dashboards
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Section assignment and deadline management
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Real-time review and approval tracking
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Integrated communication tools
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Early visibility into at-risk deliverables
User App Features
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Personalized task dashboard
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Inline review and commenting tools
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Status-driven workflows
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Real-time collaborative editing
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Smart notifications without inbox overload
AUDIT & COMPLIANCE
Built-In Traceability and Compliance
Track every edit, approval, and decision automatically.
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Hyrding creates a complete audit trail as your team works. Every version, approval, comment, and document change is recorded automatically, giving teams a clear and defensible history for inspections, reviews, and regulatory responses.
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FEATURES:
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Full document and section-level version history
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Role-based permissions and approval controls
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Timestamped approvals
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21 CFR Part 11-aligned framework
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Exportable audit trails
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Automated data integrity checks
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Compliance is built into the workflow
SUBMISSION READINESS
See Submission Readiness in Real Time
Track progress, identify risks early, and avoid last-minute surprises.
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Hyrding gives project managers and regulatory teams continuous visibility into submission completeness across every document and deliverable. Monitor progress in real time, track unresolved issues, and stay ahead of deadlines before small gaps become major delays.
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FEATURES:
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Real-time completeness dashboards
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Section-level status tracking
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Open comment and approval monitoring
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Deadline and risk alerts
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Pre-submission readiness checklists
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Cross-document validation checks
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Know exactly where your submission stands at every stage.
CROSS-FUNCTIONAL COORDINATION
One Platform for Every Team Involved
Bring Regulatory, Medical Writing, Clinical, QA, and Leadership into a shared workflow.
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Hyrding helps cross-functional teams work from the same system, reducing duplication, version confusion, and communication gaps. Shared access, role-based workspaces, and integrated collaboration tools keep everyone aligned throughout the submission process.
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BUILT FOR EVERY ROLE:
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Regulatory Affairs
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Medical Writers
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Clinical & Statistical Teams
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QA & Compliance
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Project Managers
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Leadership & Executive Review
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Hyrding integrates with Microsoft 365 and the tools your team already uses, enabling fast adoption and minimal disruption.
