Regulatory Submission Automation
Eliminate paperwork errors, reduce risk, and accelerate regulatory timelines — all with a unified, audit-ready submission system. Nutrient gives you total control over document workflows, compliance, and versioning — without the hassle of spreadsheets or scattered emails.
How We help
How we help
Replace manual tracking with a digital platform
Say goodbye to folder chaos and version confusion. Nutrient centralizes every submission document in a secure, validated system built for regulated workflows.
Keep teams aligned and inspection ready
Standardize submission assembly, review, and approval — so you always know document status and can respond to health authority questions instantly.
Automate review cycles and task routing
Assign reviewers, escalate overdue items, and route documents by submission stage, product, or geography — all with full audit trails and change logs.
Increase transparency and control
Interactive dashboards show live progress, due dates, and compliance status so regulatory, quality, and leadership teams always know what’s next.
Eliminate duplicate reviews and rework
With real-time collaboration and authoritative version control, your team works from a single source of truth and always submits the correct documents.
Scale up with regulatory complexity
Nutrient adapts to your submission formats, authority requirements, and division structures—no code needed, always inspection ready.
Key features
Key features
Visual workflow builder
Model complex submission processes — from authoring to QA to signature — with a flexible drag-and-drop interface. Assign owners, deadlines, and auto-route tasks to simplify compliance.
21 CFR Part 11 readiness
Digitally sign, lock, and retain regulatory documents in e-compliant formats, with complete audit trails, time stamps, and user authentication requirements.
Collaborative submission portal
Enable teams, reviewers, and external partners to contribute, review, and comment on documents securely — while tracking every interaction and change.
Submission progress dashboards
Monitor each step — from document drafting to health authority delivery — and view bottlenecks, risk, and timeline projections in real time.
System integration API
Sync document status, metadata, and approvals with your eCTD, EDMS, or other core regulatory platforms, automating data flows without manual uploads.
Automated compliance checks
Run built-in logic to validate submission files for format, completeness, and regulatory rules—flagging issues before they reach final review or external authorities.
Explore all our low-code document solutions
Every team, workflow, and use case is different. Nutrient offers a proven suite of tools and integrations — built to work together and designed to help you get started fast. Pick the solution that best fits your document automation needs.
Document Converter
Convert files across formats (e.g., Excel to Word or PDF) in workflows that are fast, flexible, and fully automated.
Learn MoreDocument⠀ Editor
Enable inline editing of generated Word documents—right inside your browser, with no Word installation needed.
Learn MoreDocument Searchability
Make your generated or uploaded documents text-searchable with OCR processing and metadata enhancement.
Learn MoreDocument Automation
Deploy and manage scalable, secure document automation workflows behind your firewall or in your private cloud.
Learn MoreWhy Nutrient?
No-code simplicity
Empower operations teams to own automation.
Secure by design
Built for regulated industries and compliance.
Deep Microsoft 365 integration
Seamless workflows inside the tools you already use.
Fast time to value
Stand up solutions in days, not months.
Trusted by leading organizations
Benefits
Benefits
Ensure every submission follows defined SOPs — capturing the right data, in the right format, and passing each step’s required reviews.
Ensure every submission follows defined SOPs — capturing the right data, in the right format, and passing each step’s required reviews.
Route tasks, remind reviewers, and advance submissions automatically — so filings move forward without endless check-ins.
Link directly to existing document management, quality, and submission systems for seamless, compliant data transfer.
Baked-in controls, audit trails, and role-based permissions keep every action accountable and every document inspection-ready.
Deliver a single, intuitive portal for document creation, review, and approval — with powerful, user-friendly search and reporting.
Get started today
See how modern regulatory submission automation frees your team from busywork — and lets you focus on getting products to patients, on time, every time.
Connect to your tools, your way
Workflow Automation integrates with your tech stack — including finance systems, procurement platforms, and approval tools — using APIs, webhooks, or SFTP. No extra middleware required.
Frequently asked questions
Why should companies automate regulatory submissions?
Because the stakes are high. Automation ensures consistency, improves speed, enforces compliance rules, and keeps submissions audit-ready at all times.
How does Nutrient help automate submission workflows?
Nutrient lets you create no-code workflows to assemble documentation, validate data, route for review, manage deadlines, and log every step in a secure, compliant environment.
How does this help with compliance and audit readiness?
Every submission action is time-stamped, version-controlled, and stored in a searchable audit trail — giving you full visibility and control before regulators ask for it.
Who uses regulatory submission automation?
Regulatory affairs teams, legal, quality assurance, compliance, and operations — any department responsible for getting official documents submitted accurately and on time.
Can we build custom workflows for different jurisdictions or formats?
Absolutely. Nutrient lets you configure rules and logic based on geography, document type, approval chain, and file format — so you're always compliant with specific requirements.
How fast can we launch automated submission workflows?
You can go live with a core document preparation and review flow in a few days. Full integration with your regulatory tech stack may take a few weeks.
Get started today with a free trial
See how modern regulatory submission automation frees your team from busywork — and lets you focus on getting products to patients, on time, every time.
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