Is program and submission data confidential?

Program content is never used to train any AI model. A pseudonymization layer replaces personal and organization identifiers with reversible tokens before the models see them, restoring them only in your result — automated detection reduces what reaches a provider, though it cannot guarantee elimination. Each deliberation leaves a timestamped record you can retrieve by ID. Retention periods and Zero Data Retention mode are set out in our Privacy Policy.

Does it replace regulatory affairs or our external counsel?

No. Pilot5.ai does not provide regulatory or legal advice. It argues the question an agency is likeliest to ask first, and keeps the reading that says the package will not hold, so the strategy is tested before it is filed.

What does it cost, and when in the program does it help?

The estimate is shown before the deliberation runs, reserved at launch, settled on completion, with any excess refunded — cheap enough to use at the point where a strategy is still changeable. Current rates are on the pricing page.

Who it's for / Pharma & Biotech Regulatory Affairs

Pilot5.ai for Who?

Pharma & Biotech Regulatory Affairs

GO, PIVOT or NO GO is already how you decide.
Now five independent AI models deliberate it with you.

For the regulatory lead framing the pathway. For the market access team taking the position into pricing and reimbursement. For the program owner who lives with the decision years after the meeting that made it.

Analysis grounded in regulatory guidance and published evidence. Positions that survive scientific advice and the review division. Absolute confidentiality on the asset and the data. A record of reasoning, ready for the submission file — and a tool that arms your regulatory judgment instead of replacing it.

A single AI gives one confident answer, in the same tone whether it cites real guidance or invents it — and a model trained to agree with you validates your regulatory strategy instead of testing it. On a decision that carries years of development and the program's future, that is a risk.

Step 1

The companion builds the brief with you.

The asset and the indication. The pathway you are pursuing and the alternatives you set aside. The evidence package as it stands today. The markets in scope and the review timeline you are working against.

Step 2

Research and retrieval fire in parallel.

FDA — US guidance, pathway precedent and review division expectations
EMA — EU scientific advice, guidelines and assessment practice
PubMed — published clinical and non-clinical evidence
ClinicalTrials.gov — trial design, endpoints and comparator programs
Federal Register · eCFR — US regulatory text
EUR-Lex — EU legislation for multi-market strategies

Every claim carries a provenance tag. [SOURCED] means traced to a verified reference. [INFERRED] means analytical inference — flagged automatically. Claims that cannot be traced are labelled as inference, never presented as fact.

Step 3

Five frontier AI perspectives deliberate, each through a calibrated mandate.

The Architect maps the pathway — designation, evidence package, and what the submission file has to carry.
The Strategist reads the competitive and multi-market picture the asset will meet at approval and at access.
The Engineer works the data — endpoints, trial design and whether the published evidence actually supports the claim.
The Counsel surfaces what scientific advice and the review division would question first.
The Contrarian sole mandate: argue this pathway fails at review, and name the endpoint the reviewer will not accept.

Five complete analyses. Five distinct angles. Not five versions of the same answer. Then they challenge each other, anonymously. Then they converge — and when one perspective refuses to, that dissent is preserved rather than averaged away.

Output:GO / PIVOT / NO GO / INSUFFICIENT BASIS · Confidence score · Decision matrix · Minority Report · Testable predictions.

Questions Pilot5.ai helps with

Is this the right pathway for the asset, or the one we defaulted to two years ago?
Where does our position break if the review division reads the guidance more narrowly than we do?
Does the evidence package support the indication we are asking for, or a narrower one?
What will the agency challenge first in this dossier, and what is our answer?
What changes about this strategy if we file in both markets instead of one?

Common questions

Is program and submission data confidential?: Program content is never used to train any AI model. A pseudonymization layer replaces personal and organization identifiers with reversible tokens before the models see them, restoring them only in your result — automated detection reduces what reaches a provider, though it cannot guarantee elimination. Each deliberation leaves a timestamped record you can retrieve by ID. Retention periods and Zero Data Retention mode are set out in our Privacy Policy.
Does it replace regulatory affairs or our external counsel?: No. Pilot5.ai does not provide regulatory or legal advice. It argues the question an agency is likeliest to ask first, and keeps the reading that says the package will not hold, so the strategy is tested before it is filed.
What does it cost, and when in the program does it help?: The estimate is shown before the deliberation runs, reserved at launch, settled on completion, with any excess refunded — cheap enough to use at the point where a strategy is still changeable. Current rates are on the pricing page.

Do not take our word for it. Run your own deliberation on a question you know well.

Read how five independent models handle it, then decide what it is worth.

Pilot5 delivers analysis. You deliver judgment.

Disagree to decide.

Start a Regulatory Deliberation

Read: AI decisions need an audit trail →·Read: the verified sources library →·Read: run it from your own AI →

Pilot5.ai produces AI-assisted analysis. It is not a substitute for professional regulatory or medical advice. Outputs are research and decision-support only, and must be reviewed by a qualified professional before any regulatory decision.