12-Month AI Roadmap for a 3-Person RA Team
A straightforward plan for teams that want real progress, not another “AI experiment.”
When you run a small RA team, the problem is never the people. It’s the load: too many markets, too many documents, too many deadlines.
Use case: a 3-person RA team, Class II diagnostic software, cleared in the U.S. and CE marked, planning expansion into 10 markets in 2026 (Brazil, Japan, Korea, Saudi Arabia, China, Israel, Mexico, Canada, Australia).
A good AI roadmap doesn’t add pressure; it removes it. It provides the team with a clear structure, creates momentum, and keeps everyone focused, rather than feeling overwhelmed.
Here’s a realistic 12-month plan that works for a team of three—no drama, no unrealistic promises, just a steady climb that pays off quickly.
Phase 1 (Months 1–2): Set the Foundation Without Breaking Anything
Before you bring in any serious AI, the basics need to be in order. Think of this as clearing the desk before you start building.
1. Clean and standardize your documents
Risk files, GSPR, labeling, IFUs, market dossiers; everything.
One format per document type. No variations. No “old version / new version/mystery version.”
2. Identify quick AI wins
Not for automation; to make life easier:
- Drafting
- Summaries
- Clarifications
- First-pass GSPR tables
These early wins help the team relax into the idea rather than feeling threatened by it.
3. Build a small internal prompt library
You don’t need 100 prompts. Five to ten solid ones are enough to start.
By the end of Month 2:
You’re comfortably operating around Level 2, and everyone already feels the difference.
Phase 2 (Months 3–5): Bring AI Into the Daily RA Work
Here, the team moves from “AI as a helper” to “AI as part of the workflow.”
1. Automate repetitive research
For each market:
- Requirements
- Forms
- Classifications
- Pathways
2. Let AI set up your dossier structure
The team still controls the content, but AI handles:
- TOC
- Mandatory items
- Missing elements
- Market-specific structure
3. Use AI for first drafts
Examples:
- ANVISA docs
- Saudi submissions
- Japan summaries
- Market comparisons
- Time to first draft
- Time spent researching
- Internal vs. external hours
By Month 5:
You’re in Level 3, and submissions start moving faster without the team feeling overloaded.
Phase 3 (Months 6–8): Move Toward Full Enablement
Now you start adding structure that will let you scale smoothly.
1. Build your internal “single source of truth.”
A clean, central place for:
- Product details
- Claims
- Risks
- Standards
- Labeling data
- Key technical descriptions
This is the backbone for every advanced AI capability.
2. Connect your structured data to AI agents
This allows AI to:
- Fill out key sections
- Suggest missing content
- Validate consistency
- Align documents across markets
3. Use AI to compare requirements across markets
Brazil vs. Korea
Japan vs. EU
Saudi vs. China
This becomes incredibly valuable for planning.
4. Add timeline and fee predictions
You suddenly know how long everything will take, and what it will cost, without guesswork.
By Month 8:
You’re working at Level 4, and the department feels more “in control” than ever.
Phase 4 (Months 9–12): Build the RA Digital Twin
This is the point at which AI stops being a tool and becomes an integral part of the infrastructure.
1. Automate global regulatory updates
AI can flag changes in:
- Standards
- Labeling
- Country forms
- Documentation requirements
- Risk-related updates
2. Auto-generate change-impact assessments
One change → immediate view of
- which markets it affects
- What documents need updates
- how significant the regulatory impact is
3. Produce near-complete dossiers
AI builds the structure and content.
Your team reviews, edits, and approves.
4. Run a short AI readiness audit
Make sure:
- Data is clean
- Workflows are aligned
- Everyone knows their role
- Nothing is being duplicated
By Month 12:
You’re operating at Level 5, or at least very close.
The team works faster, smarter, and with far less stress, and you’ve made your 2026 budget much leaner in the process.
Final Thoughts
This roadmap is practical because it evolves in tandem with the team.
No one is overwhelmed. Nothing feels forced.
Each phase builds confidence, structure, and capability, and by the time you reach the last quarter, the team is running on a system that feels natural.
