…. And what they mean for your 2026 budget
RA teams are under pressure to support more markets, shorter cycles, and increasing global complexity. AI is now mature enough that different levels of adoption directly translate into quantifiable time and budget shifts, especially for small teams.
The real question isn’t whether RA teams should adopt AI; it’s how far they want to go, and how much time and budget they want to save in 2026.
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)
Summary of the 5 Levels
- Basic Productivity – LLM for summaries and drafts
- Structured Assistance – Templates + controlled prompting
- Integrated Workflow – AI agents automate research + drafting
- Full Enablement – AI generates submissions + compliance matrices
- Digital Twin – Autonomous RA operations, humans review only
Level 1: Basic Productivity Assist (LLM-as-a-Toolbox)
“LLM on the side, helping here and there.”
Typical tools: general LLMs, basic prompts, light summarization
What it does:
- Summaries of standards, regulations, and guidance
- Drafting emails, meeting notes, and simple text cleanup
- Quickly checking terminology, definitions
Impact:
- Saves time, but not mission-critical
- Minimal budget impact — maybe enough to reduce overtime and stress
- No real change in how the RA team works
For your 2026 budget: This level is basically “AI as a personal assistant,” not process automation.
Level 2: Structured RA Assistance (Controlled Prompting + Templates)
“We now use AI consistently, but in predefined ways.”
Typical tools:
- Prebuilt RA prompt libraries
- Standardized templates for labeling, GSPR, and risk tables
- Company-specific formatting rules stored in the system
What it does:
- Produces first drafts of compliance documents
- Helps prepare technical dossiers
- Creates country-specific requirement checklists
- Speeds up comparisons (FDA vs CE vs Brazil, etc.)
Impact:
- 20–30% time saved on document drafting and research
- More predictable quality
- The team still controls everything manually
For your 2026 budget: This is where the first meaningful cost savings appear.
Level 3: Integrated RA Workflow Automation (AI Agents in the Workflow)
“The RA team works with AI like an extra junior colleague.”
Typical tools:
- Multi-agent systems (research + comparison + drafting + QC)
- Automated requirement retrieval per country
- Smart forms that prebuild the RA documentation structure
- Early RAG with curated regulatory data
What it does:
- Fetches and compares regulatory requirements for each market
- Pre-generates 70–80% of technical documents
- Structures registration packages
- Flags missing elements
- Creates timelines, fees, and checklists
Impact:
- 40–60% faster submissions
- More submissions completed by the same 3-person team
- Reduces dependency on external consultants
For your 2026 budget: This is where the budget for 2026 starts to change dramatically; more markets per dollar.
Level 4: Full RA Operations AI Enablement (Semi-Autonomous RA)
“Regulatory AI works as a mid-level RA specialist.”
Typical tools:
- Advanced RAG connected to curated regulatory repositories
- Auto-generated submission packages per country
- AI-driven risk analysis and GSPR mapping
- AI-generated labeling adapted per market
- Predictive analytics: timelines, fees, expected authority questions
What it does:
- Provides near-complete draft submissions for Brazil, Korea, Japan, Saudi Arabia, and others.
- Auto-generates local forms
- Connects product changes to regulatory impact
- Produces ready-to-review versions of almost all documents
- Answers internal questions (“What do we need in Korea for this SW?”) instantly
Impact:
- Reduces registration cycle time by 60–80%
- A team of 3 can operate like a team of 7–8
- Significant reduction in consulting spend
- The 2026 budget can include more markets without adding headcount
For your 2026 budget: This is where the ROI becomes undeniable. A three-person team now performs like a whole department.
Level 5: End-to-End RA Digital Twin (Autonomous RA Operations)
“The RA department runs digitally. Humans review and approve.”
Typical tools:
- A full RA Digital Twin containing:
- product → design → compliance matrix
- labeling → risk → standards updates
- authority requirements → forms → submission simulators
- Autonomous agents that run entire research cycles
- API connectivity with LMS, QMS, and PMS systems
- Version-aware global regulatory mapping
- Real-time change assessment
What it does:
- Automatically updates global requirements
- Auto-populates the entire submission structure
- Prepares and simulates authority review
- Flags gaps before the humans notice
- Maintains global license lifecycle
Impact:
- Team of 3 manages 10–15 markets per year with ease
- 90% of research and 80% of document assembly is automated
- The budget shifts from “people cost + consultants” to “platform cost + reviewers”
- Submission readiness becomes predictable and scalable
Next week, we will be discussing How a Small RA Team Should Measure AI Impact, choose the Right Level of Adoption, and navigate the Transition