AI Pharmaceutical Copywriting Enginev2.4.1 — production
prescribe_engine.rx — active session
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FDA Guidance Compliant21 CFR Part 202AMA Style EnforcedMLR Package IncludedClaim Matrix Auto-GeneratedZero Hallucinated AssertionsHCP EmailsPI SummariesCongress AbstractsBrand Lexicon AdaptiveFDA Guidance Compliant21 CFR Part 202AMA Style EnforcedMLR Package IncludedClaim Matrix Auto-GeneratedZero Hallucinated AssertionsHCP EmailsPI SummariesCongress AbstractsBrand Lexicon Adaptive
01 / The Bottleneck

Fourteen days to move
one paragraph.

Every promotional email, every HCP leave-behind, every PI summary passes through the same gauntlet. Medical. Legal. Regulatory. Revision. Repeat. Your MLR cycle isn't a process — it's a waiting room.

14days
Avg. MLR cycle per asset
43%
Submissions need a second cycle
2.3×
Average revision rounds
Day 1
Brief received

Brand team hands off data package

Day 2–3
Copy drafted

Agency writer researches & writes first draft

Day 4–5
Internal review

Brand manager feedback cycle

Day 6–8
Medical review

Medical affairs checks every claim

Day 9–10
Legal review

Regulatory counsel checks every statement

Day 11–12
Revision loop

2.3 rounds of revisions on average

Day 13
MLR submission

Final package assembled and submitted

Day 14+
Approval (maybe)Bottleneck

43% of submissions require a second cycle

02 / The Engine

Same pipeline.
Eighteen minutes.

Prescribe doesn't accelerate the old process — it replaces it. The model reads your data, writes to your style guide, cites every claim, and hands your reviewer a complete MLR package before their first coffee.

14d→ draft to MLR-ready
0:00
Data ingested

Clinical endpoint, FDA ref, style guide loaded

0:02
Claims mapped

Every assertion linked to an approved source

0:08
Draft generated

AMA-styled paragraph with inline citations

0:14
MLR package assembled

Claim matrix, source links, style compliance report

0:18
Review-ready✓ Complete

Submitted with zero ambiguous claims

Ingests your data corpus

Clinical trial CSRs, FDA guidance documents, prescribing information, and brand lexicons — loaded once, referenced on every draft.

Traces every claim

No assertion appears without a traceable citation. The model refuses to generate unsubstantiated language — by design, not by prompt.

Outputs the MLR package

Alongside the copy, Prescribe generates a claim matrix with source references — the exact document your medical reviewer needs to approve in hours.

03 / Compliance Built In

Not compliant by luck.
Compliant by architecture.

The model doesn't guess and check. It references first, writes second. Every claim is traceable before the sentence ends.

CLAIM TRACEABILITY

Every assertion has a zip code.

Prescribe won't write a sentence it can't source. The model is trained to refuse unsubstantiated language — not suppress it after the fact, but structurally prevent it at generation time.

Source: KEYNOTE-522, Table 3, p.12 → Claim ID: PEM-001
100%
Claims traceable to source
0
Hallucinated assertions
21 CFR
Part 202 compliant
AMA
Style enforced by default
04 / Therapeutic Breadth

One engine.
Every indication.

Prescribe doesn't need a different model for oncology versus immunology. It adapts voice, terminology, and citation conventions to your therapeutic area — automatically.

oncology_hcp_email.rx
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Key terminology loaded
Immuno-oncologyTNBCCheckpoint inhibitorsHER2+ADC
Corpus size140+oncology trials in corpus