Health authority query response with a cited draft for every question — and a check of what every other agency was told
Cited first drafts within hours, consistent with every past answer to every agency.
See one case, screen by screen ↓An FDA information request names a response date days out; an EMA Day 120 list can carry 86 questions. The regulatory lead pastes the questions into a tracker spreadsheet and emails each one to a topic owner in CMC, clinical pharmacology, immunogenicity, safety, statistics or labeling. Each owner searches the eCTD sequences and a shared drive of old responses by hand, writes in Word, and the answers go round in review before they are signed and handed to regulatory operations to publish.
The same product is under review in several markets at once, so the same fact — the ADA rate, the shelf life, the data cut — is answered again and again for different agencies, sometimes from different data. A second agency given a different number opens a new question, and sometimes a credibility problem in review. Today it is caught only if someone remembers what was sent in July.
Estimated split for a 12-question FDA information request, by hand and with the solution. Owner review stays with the owners.
Six specialist agents split, route, find, draft and check every reply against what each agency was told; owners review and the regulatory lead signs.
Kestrow Biologics has Veltrimab, a 150 mg/mL biologic, under review in the US, the EU, Canada and Switzerland. On Tuesday 6 October 2026 at 08:12 the FDA sends an information request on BLA 761904. Here is what happens next, screen by screen, in the working solution.
Maya's query inbox holds nine open letters across Veltrimab, Talmirex and Corventa, each with its clock. At the top: the FDA information request, 12 questions, due Fri, Oct 16 — 10 days. Before anyone splits it, the right pane shows that 2 of the letter's topics were told differently before: the treatment-emergent ADA incidence and the prefilled syringe shelf life.
“Letters from the FDA portal, EMA IRIS and agency email arrive here on their own.”
The question splitter finds 12 numbered questions under 7 review headings and keeps the agency's wording. The owner router assigns 7 owners from the approval rules. The dossier retriever finds 16 passages in Modules 2, 3 and 5 and 7 related past answers. The response drafter writes 12 drafts with 24 citations, and the consistency checker compares every number with what other agencies were told.
Each step runs in view, with what it found — 2 differences: ADA rate (Health Canada) · shelf life (Swissmedic draft).
Twelve questions, 7 owners, 0 of 12 signed, 1 waiting on data, 2 told differently elsewhere. Question 1 asks for the justification of the HCP criterion of NMT 100 ppm: the draft cites 14 clinical and 3 PPQ drug substance lots at 8 to 41 ppm and the 82% ELISA coverage by 2D-DIGE Western blot. Its chip reads “Same as 1 other agency” — the EMA Day 120 answer of Jul 30.
The FDA asks for ADA and NAb incidence through Week 52 in Study VLT-302. The draft says 4.8% — 31 of 642, Week 52 cut — the same as the EMA answer of Jul 30. But Health Canada was told 4.6%, 29 of 630, on Aug 21, from the Week 40 interim cut. The checker flags it in amber, explains it and proposes a fix; it does not change the reply itself.
“Both are right for their data cut — the reply should say which cut it uses.”
Maya clicks “Add a data-cut note”. The reply now ends: “All figures use the Week 52 data cut (database lock March 14, 2026); our response to Health Canada of August 21, 2026 used the Week 40 interim cut (4.6%, 29 of 630 patients).” The flag turns to Explained.
“Data-cut note added — the difference is explained in the reply.”
Question 7 goes to Priya, its owner, with Maya as signer. The draft carries high confidence (0.93), reuses the EMA answer of Jul 30 and cites its dossier sources at the page — among them the Integrated Summary of Immunogenicity at Module 5.3.5.3, §4.2, Table 6, page 14, and the VLT-302 study report at §11.4.3, page 212. It shows that it covers every part: ADA and NAb incidence, effect on PK, on efficacy, on safety, and assay drug tolerance.
Maya cannot sign before the owner: “The owner, Dr. Priya Raman, reviews first — then you sign.”
Told to agencies lays out 9 facts given to 4 agencies for Veltrimab, each against its dossier value. The shelf life row shows the second difference: the dossier and the FDA draft say 24 months, the EMA was told 18 months on Jul 30 with the data then available, and the Swissmedic draft still says 18 months, copied from that July answer. One click aligns Swissmedic to 24 months.
Earlier values superseded by newer data are struck through, not flagged.
The tracker shows the letter with each question highlighted, every owner and stage. Question 4, on Protein A eluate hold times, needs data: bioburden and endotoxin results from the 96-hour hold study, which Plant 3 — Leiden expects to send on Oct 12. Question 12 waits for Omar Haddad's tipping-point tables on Oct 13. The response package for eCTD sequence 0012 is built only from signed answers.
Health Canada's clarification request on Veltrimab is due Oct 14, 8 days left, 3 of 5 signed. Question 3 asks to update the ADA incidence with the Week 52 data; Priya has reviewed it. Maya signs with her name, password and the meaning of her signature: “I approve this answer for submission to the agency.”
“Your name, the date and time, and the meaning of this signature are recorded in the audit trail with this version of the answer.”
The answer is signed by Dr. Maya Chen at 08:16 and the letter moves to 4 of 5 signed. The reply says plainly what it changes: it updates Health Canada from 4.6% (Week 40 interim cut, sent Aug 21) to 4.8% (Week 52), as the agency asked. Regulatory operations publishes once the package is signed.
“Updates an earlier answer.”
The same letter, seen by the people who carry it — what their review cycle looked like, and what it looks like now.
Six specialist agents split, route, find, draft and check every reply against what each agency was told; owners review and the regulatory lead signs.
Reads each agency letter — FDA, EMA, Health Canada, PMDA, MHRA, TGA and Swissmedic formats — and returns every numbered question with its sub-parts, the review heading it sits under and the agency's due date.
Classifies each question by topic and eCTD section, assigns the owner and approver from the approval rules for that topic and product, and notifies owners with the due date.
Finds the exact passages, tables included, in the current dossier sequences and the approved past answers on the same topic for the same product, across every market.
Writes a direct answer to every sub-part in plain, factual regulatory English and the house style for the agency, citing the dossier passage for every number and reusing approved wording when the data are the same.
Compares each draft with every earlier answer for the same product in every market — numbers, data cuts, shelf lives and claims — explains any difference in one sentence and proposes a fix.
When every answer is signed, assembles the response document in the agency's question order, the attachments, the cover letter and the eCTD sequence details for regulatory operations.
Signs after owner review. The agents propose; a named person decides.
Ask about any agency query, reply or clock in plain words — or say what to change. Answers come from the agency letters, the submitted dossier and every past response.
Which replies could miss the Oct 16 clock?
Two of twelve replies are at risk for the FDA request due Oct 16: question 4, hold times — the Protein A eluate data are not in the dossier, and Plant 3 — Leiden expects to send them on Oct 12; and question 12, the tipping-point analysis — Omar Haddad expects the tables on Oct 13. Question 11 follows once question 7 is signed.
Have we ever told an agency a different ADA rate for Veltrimab?
Yes, once. Health Canada was told 4.6% on Aug 21, from the Week 40 interim data cut. The EMA answer of Jul 30 and today's FDA draft use the Week 52 cut: 4.8%. Both are right for their data cut. A one-line data-cut note in FDA question 7 is suggested.
Add a rule: every reply must state its data cut
Done. New drafting rule: “State the data cut for every number taken from a clinical study.” It applies to every new draft from now on and is listed under Settings → Drafting rules. The consistency checker will flag any reply without it.
Draft the cover letter for the FDA response package
Drafted the cover letter for BLA 761904, eCTD sequence 0012, as the response to the information request of October 6, 2026. It lists the 12 replies and 7 attachments and is addressed to the Regulatory Project Manager. It is in the response package, waiting for your signature.
13 screens from the working solution, on its sample data. Pick one to see it large.
Reminders, approvals and the rules every draft follows are settings — and a new rule can be described in plain words.
| Setting | Default | Choose from |
|---|---|---|
| Remind owners before the due date | 5, 3 and 1 days | 5, 3 and 1 days · 7, 3 and 1 days · 3 and 1 days |
| Internal target | 2 days before the agency's date | Step up or down, one day at a time |
| Escalate when an answer is late | On — the regulatory lead is told | On · Off |
| Owner per topic | Immunogenicity: Dr. Priya Raman | Any question owner, for each of Quality (CMC), Clinical pharmacology, Immunogenicity, Clinical efficacy, Safety, Statistics and Labeling |
| Final sign-off | Dr. Maya Chen | Dr. Maya Chen · Dr. Jonas Weber |
| Cite a dossier passage for every number | On — drafts without a source are blocked | On · Off |
| Reuse approved past answers | On — signed and sent, same product only | On · Off |
| House style: US English, past tense for study results | On — applied to FDA answers; British English for EMA, MHRA and TGA | On · Off |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample product data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · Agency clocks vary; 10 days is shown as an example. People, companies, products and application numbers named on this page are fictional — characters and sample data in the working solution.
Health authority query (HAQ) management is how a regulatory team receives, answers and tracks the questions agencies send during review — FDA information requests and review letters, EMA Day 120 and Day 180 lists, Health Canada clarification requests and others. Health Authority Query Response does it as an inbox: each letter is split into its questions, and each question arrives with a cited draft reply, an owner and the agency's clock.
The dossier retriever finds the passages in the current eCTD sequences and the approved past answers on the same topic. The response drafter writes a direct answer to every sub-part in the house style for that agency, with a citation for every number, and shows which parts of the question it covers. The topic owner reviews and edits it.
The consistency checker compares every number and data cut in a draft with what each agency has been told about the same product. A difference is flagged with its reason and a fix — such as adding a data-cut note or aligning a draft to the current dossier — and the Told to agencies grid shows every fact by agency. Earlier values that newer data superseded are struck through, not flagged.
No. Every number must cite a dossier passage, and a draft without a source for a number is blocked. Only current submitted sequences and past answers that were signed and sent are used, and statements that could open a new question are flagged.
FDA information requests and discipline review letters, EMA Day 120 lists of questions and Day 180 lists of outstanding issues, Health Canada clarification requests, PMDA inquiries, MHRA requests for further information, TGA section 31 requests and Swissmedic lists of questions. Letters from the FDA portal, EMA IRIS and agency email arrive in the inbox on their own; others can be added.
Yes. Agents draft and propose; they never send. The topic owner reviews each reply, the regulatory lead signs each answer and the package with an e-signature that records its meaning, and regulatory operations sends the eCTD sequence.
Yes. Reminders, the internal target before the agency's date, escalation, the owner for each topic, the final signer, the drafting rules and house style per agency are settings. A new rule can be described in plain words — for example, that every reply states its data cut.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your approval rules, house style, submitted dossier and a sample of past agency letters and responses — and it goes live once every quality gate has passed. We will walk you through it on your own letters first.
Every agency change reaches the right team within hours, with what changed marked.
1-min demoCTD Module 2 AuthoringModule 2 summaries drafted in weeks, every statement cited to its source.
1-min demoCCDS Label Change ManagementEvery local label a CCDS change touches found, with every market on a clock
1-min demoWe'll run Health Authority Query Response on a sample of your own past agency letters and responses.