AI Agents for Life Sciences Regulatory Submissions
AI agents for life sciences regulatory submissions gather source documents, check them against your submission plan and format requirements, track open items and prepare each package for regulatory affairs review. Regulatory teams manage exceptions and sign-off, not document chasing.
Challenges We Solve
Where Regulatory Submissions Break Down
Regulatory affairs teams collect documents from many functions, check them by hand against a submission plan and assemble packages under deadline pressure.
Collection
Documents arrive from many functions at different times
Clinical, quality, nonclinical and CMC teams each deliver content on their own schedule. Regulatory affairs tracks what is outstanding in spreadsheets and email.
Plan
The submission plan is tracked manually
Each document in the plan has an owner, a due date and a status. Keeping the tracker current is a job in itself.
Format
Format and metadata errors are found late
File names, bookmarks, hyperlinks and metadata must meet publishing requirements. Problems found at the end force rework before the deadline.
Consistency
Content is not consistent across documents
Product names, study identifiers and figures must match across modules. Cross-checking by hand misses differences.
Versions
Document versions are hard to control
Final and draft versions sit in several repositories. Teams risk including the wrong version in a package.
Evidence
Submission history is hard to reconstruct
Questions from authorities require showing what was submitted and when. Records are spread across systems.
AI Agent Capabilities
AI Agents Built for Every Regulatory Submission Workflow
Six connected capabilities designed around your submission plans, publishing requirements and document repositories for regulatory affairs teams.
Document Collection Agent
- Tracks every document in the submission plan with owner, due date and status
- Requests outstanding documents from authors and reviewers
- Pulls approved versions from your document repositories
- Flags documents that are late or still in draft
- Shows readiness by module and section
Format Check Agent
- Checks file type, naming, bookmarks, hyperlinks and metadata against your publishing requirements
- Flags documents that need correction with the specific issue
- Returns findings to the author or publisher
- Re-checks after correction for each submission
- Keeps a record of each check
Consistency Check Agent
- Compares product names, study identifiers, dates and key figures across documents
- Flags differences between modules and sections
- Shows each difference with its source location
- Routes findings to the document owner for each submission
- Records how each finding was resolved for each submission
Package Assembly Agent
- Assembles documents into the structure your submission plan defines
- Applies the naming and ordering rules you approve
- Prepares the package for your publishing tool or review
- Keeps version history for each assembled package
- Leaves final approval to regulatory affairs
Open Item Tracking Agent
- Tracks open items, owners and due dates across the submission
- Sends reminders ahead of internal deadlines for each submission
- Escalates items at risk of missing the date
- Shows what changed since the last status meeting
- Reports readiness to the submission lead
Submission Record Agent
- Records what was submitted, when and by whom
- Links each submission to its source versions and checks
- Keeps correspondence with authorities alongside the submission
- Builds a history for authority questions and audits
- Reports on submission timelines across products
Deployment
How We Deploy Your Regulatory Submissions Agent
Five steps from your first call to a validated submission workflow connected to your document repositories and publishing process.
01
Submission Plan and Repository Review
We map your submission plans, document owners, publishing requirements, repositories and the way packages are assembled and approved today.
✓ Submission plan and document owner inventory
✓ Repository and publishing workflow map
✓ Recommended agent architecture for your environment
BUILT FOR LIFE SCIENCES REGULATORY AND QUALITY TEAMS
The right submission visibility for every regulatory role
Each deployment is scoped around how a specific role depends on submission documents. Regulatory affairs, authors and quality leaders each get the outcome they need without tracking documents by hand.
REGULATORY
Regulatory Affairs Manager
Stops tracking the plan in a spreadsheet. Sees readiness by section and open items.
What Changes
- Every planned document tracked with owner and status
- Format and consistency findings before assembly
- Packages prepared in the structure your plan defines
- Final approval kept with regulatory affairs
AUTHOR
Document Author or Owner
Stops getting last-minute requests. Receives clear reminders and specific findings.
What Changes
- Reminders ahead of internal deadlines
- Findings shown with the exact issue and location
- Re-check after correction
- Fewer late changes to approved documents
QUALITY
Quality or Compliance Lead
Stops reconstructing submission history. Has the record ready.
What Changes
- What was submitted and when, in one record
- Versions linked to the checks performed
- Correspondence kept with each submission
- History available for authority questions and inspections
Meet Our CEO Haroon Jafree, CPA
25 years as a CFO and finance leader, designing agents around workflows he personally ran.
FAQ
Questions About Regulatory Submission Automation
What regulatory affairs managers, authors and quality leaders ask before the first call.
It uses AI agents to track documents against your submission plan, check format and consistency, assemble packages and keep a record of what was submitted. Regulatory affairs reviews and approves each package before it goes out.
Get Started
Ready to Stop Chasing Submission Documents?
Book a discovery call to walk through your submission plan, your document repositories and your publishing process.
Book a Discovery Call →