WorkflowRegulatory Affairs

Agency Question Response

Answer every health authority information request with a cited first draft within hours, consistent with every past answer

Every agency question gets a cited first draft within hours, consistent with every past answer.

Watch the film Book a demo

See one case, screen by screen ↓

demo3.9hoursmedian from agency letter to first drafts, against 4.5 days before the agents

demo0conflicting answers sent to an agency — 27 caught by the consistency checker first

target9daysleft for expert review on a 10-day agency clock

target44%of answers start from an approved past answer, checked in every market

The problem

Why agency responses eat the clock

An FDA information request lands at 08:12 with twelve questions and a ten-day clock. Before anyone can answer, someone has to number the questions, work out which belong to CMC, clinical pharmacology, immunogenicity, safety, labeling and statistics, and chase the right owner for each — then everyone goes looking for the dossier section, the table and the past answer that settles it.

The slowest part is not writing. It is finding the passage, and making sure the number matches what was already told to every other agency. An ADA rate from the Week 40 interim cut sent to Health Canada and a Week 52 rate sent to EMA are both right, but put side by side without a note they read as a contradiction — and a contradiction is a new question.

demo4.5daysfrom agency letter to first drafts, before the agents

demo10daysto answer all twelve questions in the FDA request

demo2,940past answers in the library, signed and sent, that a new answer is checked against

Where a response’s days go (in days)estimated

By hand6.5 days

With the solution0.7 days

Splitting the letter and assigning owners0.5 → 0.1 d
Finding dossier passages and past answers2 → 0.1 d
Writing first drafts2 → 0.1 d
Checking against earlier answers1 → 0.2 d
Building the response package1 → 0.3 d

Estimated split for a 12-question information request, by hand and with the solution.

How it works

How a question moves

Six specialist agents split, route, find, draft, check and package every answer; owners review and the regulatory lead signs.

What comes in

Letters inAny agency · portal, email or upload

Agents at work

Question splitterone per question

Then

Owner router

Dossier retriever

Then

Response draftercited draft

Then

Consistency checkerevery market

Then

Package assemblerletter + attachments

A person decides

Regulatory leadsigns after owner review

What comes out

Signed answers

Response package

Clock met

One case, step by step

One FDA information request, from letter to signed answers

On October 6 the FDA sends twelve questions on the Veltrimab biologics license application, BLA 761904, with a response due October 16. Here is what happens next, screen by screen, in the working solution.

01Oct 6
Every open agency clock, on one screen
Dr. Maya Chen · Regulatory lead
Maya opens the solution and sees where every request stands: 9 open requests from 7 agencies across 3 products, 129 questions still open, 5 answers reviewed by owners and waiting for her signature. The newest clock is the FDA’s on Veltrimab: 10 days, due Oct 16.
Consistency checks: “Shelf life — Veltrimab prefilled syringe · Swissmedic draft says 18 months · FDA answer confirms 24 months.”
0208:12
The letter arrives from the FDA portal mailbox
Dr. Maya Chen · Regulatory lead
IR_BLA761904_2026-10-06.pdf arrives on its own from the FDA portal mailbox. Maya reads it in the solution: product quality questions on host cell protein, stability, leachables and hold times, then clinical pharmacology, immunogenicity, clinical efficacy, safety, labeling and statistics — “We request a written response by Oct 16, 2026.”
03One click
“Split and assign” — and the agents start
The agents
The agents read the four-page letter, split it into 12 numbered questions under 7 review headings, assign 7 owners from the approval rules, find 16 passages in Modules 2, 3 and 5 and 7 related past answers, and draft every answer. Then they check each draft against earlier answers and start the response clock, with reminders at 5, 3 and 1 days.
“12 drafts · 24 citations · every number cited.”
04By 15:40
Twelve questions, each with an owner and a stage
The question owners
Each question in the letter is now tagged Q1 to Q12, and the due date is highlighted. The tracker shows who owns what: Sam Patel for CMC, Lena Ortiz for clinical pharmacology, Dr. Priya Raman for immunogenicity, Dana Okafor for safety. By mid-afternoon 8 of 12 are approved; question 4 waits on Plant 3 — Leiden for hold-time data.
05Owner review
Question 7, drafted from the dossier
Dr. Priya Raman · Bioanalytical & immunogenicity
The FDA asks for the ADA and neutralizing antibody incidence through Week 52 of Study VLT-302, the impact on PK, PASI 75 and safety, and the drug tolerance of the assay. The draft answers every part with five sources cited — 31 of 642 patients (4.8%) with treatment-emergent ADA, 9 (1.4%) with neutralizing antibodies — and reuses the EMA answer of Jul 30. At 13:52 Priya changes “no impact” to “no hypersensitivity event was associated”, and at 14:20 she marks it reviewed.
“Covers every part: ADA and NAb incidence · Effect on PK · Effect on efficacy · Effect on safety · Assay drug tolerance.”
06Before signing
Every number opens at its passage
Dr. Maya Chen · Regulatory lead
Maya clicks the first citation. The Integrated Summary of Immunogenicity opens at Module 5.3.5.3, §4.2, Table 6, page 14, with the sentence the number comes from highlighted — the same passage the FDA can read in the dossier.
07Flagged
A different data cut, caught before it is sent
Consistency checker
The consistency checker has flagged what nobody went looking for: Health Canada was told 4.6% on Aug 21, 2026 from the Week 40 interim cut. This draft uses the Week 52 cut, the same as the EMA answer. Both numbers are right — so Maya adds a one-line data-cut note, and the check turns green: consistent with 3 earlier answers.
Added to the answer: “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).”
08Signed
The regulatory lead signs the answer
Dr. Maya Chen · Regulatory lead
Maya signs question 7 with her name and password. The meaning of the signature — “I approve this answer for submission to the agency” — is recorded in the audit trail with the date, the time and this version of the answer. The request moves to 9 of 12 approved, and Ruth Mensah is told that question 11, the labeling change that depends on it, can now be finalized.
09Package view
The response package, built from signed answers only
Package assembler
The package for eCTD sequence 0012 lays out the cover letter (drafted when the package is built), the question-by-question response in the agency’s order, the attachments and the eCTD sequence details mapped to sections. At 8 of 12 answers signed, 5 of 7 attachments are ready; it shows what it still waits on: question 4 (hold-time data) and question 12 (tipping-point tables).
“Built only from signed answers. You sign the package before regulatory operations sends it.”
10Last 90 days
Every clock met, no conflicting answer sent
Dr. Maya Chen · Regulatory lead
Over the last 90 days: 412 questions answered across 7 agencies, 13 of 13 responses on time, a median of 3.9 hours to first draft, and no conflicting answer sent — 27 caught by the consistency checker first. Owners changed 14% of drafted sentences before signing.

Who it’s for

Built for everyone who answers to an agency.

The same FDA request, seen by four of the people who carry it — what their week looked like, and what it looks like now.

Dr. Maya ChenRegulatory lead

Regulatory lead

Before: Pieces together who owns which question and chases drafts while the agency clock runs.
Now: Opens a request already split, owned and drafted; signs each answer after its owner reviews it.

Dr. Priya RamanBioanalytical & immunogenicity

Question owner

Before: Goes back to the immunogenicity summary, the study report and the assay validation for every new question.
Now: Reviews a draft with every number cited at its passage, edits one sentence, and marks it reviewed.

Sam PatelCMC regulatory

Question owner

Before: Answers stability and specification questions that EMA, Swissmedic and the FDA each asked in their own words.
Now: Starts from the approved past answer, and sees at once when a draft’s shelf life differs from what another agency was told.

Ruth MensahLabeling

Question owner

Before: Waits to hear when the clinical answer her label text depends on has been signed.
Now: Is told the moment question 7 is signed that question 11, the label section, can be finalized.

Built on the engine

6 agents. Each with one job, and hard limits.

Six specialist agents split, route, find, draft, check and package every answer; owners review and the regulatory lead signs.

Question splitter

Reads each agency letter and splits it into numbered questions with their sub-parts, the review discipline each sits under, the due date and whether the clock counts calendar or business days.

Keeps the agency’s wording verbatim
Never merges sub-parts across numbered questions
Flags a letter with no due date for a person

Owner router

Classifies each question by topic and eCTD section and assigns the owner and approver from the approval rules, then notifies owners by email with the due date.

Never assigns an approver who is the owner
Escalates when no owner is available

Dossier retriever

Finds the dossier passages, tables included, and the past answers that bear on each question, across every eCTD sequence and market.

Uses only current, submitted sequences
Reuses only approved and sent past answers

Response drafter

Drafts a direct answer to every sub-part in the house style, cites the dossier passage for every number and lists what the answer covers.

Every number cites a dossier passage
No new data or claims beyond the dossier
Flags statements that could open a new question

Consistency checker

Compares every draft with every earlier answer for the same product in every market, and flags different numbers, data cuts, shelf lives or claims with a one-sentence reason and a proposed fix.

Never resolves a flag on its own — a person decides

Package assembler

When every answer is signed, assembles the response document in the agency’s question order, attaches the attachments, drafts the cover letter and prepares the eCTD sequence details for regulatory operations.

Builds only from signed answers
The regulatory lead signs before anything is sent

Regulatory lead

Signs after owner review. The agents propose; a named person decides.

Ask in plain words

Ask about any request, answer or clock

The assistant answers from the agency letters, the submitted dossier and every past response — and changes the screens when you ask it to.

Which answers could miss the Oct 16 clock?

Two of twelve answers are at risk for the FDA request due Oct 16: question 4, hold times — waiting on Plant 3 — Leiden for bioburden data; and question 12, tipping-point analysis — Omar Haddad expects the tables on Oct 13. Question 11 follows as soon as you sign question 7.

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. I suggest a one-line data-cut note in FDA question 7.

Add a rule: every answer 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 answer 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 answers and 7 attachments and is addressed to the Regulatory Project Manager. It is in the response package, waiting for your signature.

Every screen

The working solution, as it ships.

13 screens from the working solution, on its sample data. Pick one to see it large.

Agency Question Response — Home — **Home**Open requests, questions still open, answers waiting for the regulatory lead’s signature, the newest clock and the consistency checks raised today.

Agency Question Response — Every request — **Every request**Every open letter from FDA, EMA, Health Canada, PMDA, MHRA, TGA and Swissmedic, with questions approved, the lead, the due date and days left.

Agency Question Response — The agency letter — **The agency letter**The FDA information request as received, ready to split into questions and assign to owners.

Agency Question Response — Agents at work — **Agents at work**Each step runs in view: the letter read, the questions split, owners assigned, passages found, answers drafted and checked.

Agency Question Response — The response tracker — **The response tracker**Every question tagged in the letter, with its topic, eCTD section, owner and stage, and the clock counting down.

Agency Question Response — One answer, side by side with its sources — **One answer, side by side with its sources**The question, the draft with every number cited, the parts it covers, the owner and the regulatory lead — with sources and past answers alongside.

Agency Question Response — Open at the passage — **Open at the passage**Any citation opens the dossier page it comes from, with the sentence highlighted.

Agency Question Response — Consistency check — **Consistency check**A differing data cut flagged against the Health Canada answer, resolved with a one-line note — now consistent with 3 earlier answers.

Agency Question Response — Electronic signature — **Electronic signature**The regulatory lead signs with name, password and the meaning of the signature, recorded with this version of the answer.

Agency Question Response — The response package — **The response package**Cover letter, question-by-question response, attachments and eCTD sequence details — built only from signed answers.

Agency Question Response — The library — **The library**2,940 past answers with who signed them, when they were sent, their data cut and how often each was reused — plus the dossier and every agency letter.

Agency Question Response — The dashboard — **The dashboard**Time to first draft, responses on time, questions answered, conflicting answers sent, open agency clocks and where answers came from.

Agency Question Response — Your team’s rules — **Your team’s rules**Response clocks, reminders, escalation and the owner and approver for every topic — all settings.

Governance

Built for regulatory work: cited, consistent, signed.

Every number cites the dossierEach number in an answer cites a passage in the submitted dossier, and opens there with the sentence highlighted. Drafts without a source for a number are blocked.

Only what was submitted and sentDrafts draw only on current, submitted eCTD sequences, and reuse only past answers that were signed and sent, for the same product.

The owner reviews, the lead signsAn answer joins the package only after its owner reviews it and the regulatory lead signs it. The name, date, time and meaning of the signature are recorded with that version of the answer.

Checked against every earlier answerEvery draft is compared with what each agency was told before, in every market. A differing number or data cut is flagged — and a person decides how to resolve it.

Nothing leaves without a signatureThe response package is built only from signed answers, and the regulatory lead signs the package before regulatory operations sends it.

Every edit on the recordEach agent step, edit and signature is in the answer’s history, with version history kept for every change — who, what and when.

Configuration

Your team’s rules, not ours

Clocks, owners, sign-off and drafting rules are settings your regulatory lead changes, not a project.

Setting	Default	Choose from
Remind owners before the due date	5 · 3 · 1 days	5 · 3 · 1 days · 7 · 3 · 1 days · 3 · 1 days
Internal target: answers approved before the agency’s date	2 days	Any number of days
Escalate when an answer is late	On — the regulatory lead is told	On · Off
Owner for each topic	Quality (CMC): Sam Patel	Any person on the team, per topic
Final sign-off, for every answer and the package	Dr. Maya Chen	Dr. Maya Chen · Dr. Jonas Weber
Cite a dossier passage for every number	On	On · Off
Reuse approved past answers	Signed and sent, same product	On · Off
House style	US English for FDA answers	British English for EMA, MHRA and TGA · your own rules in plain words

Connections

Works with the systems you already run

Agency mailboxesFDA portal mailbox, EMA IRIS notifications, Health Canada and Swissmedic email

Letters by uploadPDF, Word or email — agency and product detected from the letter

Submitted dossierevery eCTD sequence, indexed by section, table and passage

Past responses libraryevery answer sent, with who signed it and its data cut

Email and calendarsowners notified with the due date, out-of-office respected

Regulatory operationsthe response package and eCTD sequence details, for submission

What it changes

The difference, in numbers.

Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.

target

4hours

from agency letter to first drafts

By hand≈ 4.5 days

With agents≈ 4 hours

target

9days

left for expert review on a 10-day agency clock

Drafts on day 1
for every question in the letter

target

44%

of answers start from an approved past answer, checked in every market

reuse an approved past answer

“demo” = seen in the working solution, on its sample data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · Agency clocks vary; 10 days shown as an example. People, products and applications named on this page are characters and examples in the working solution.

Questions

What regulatory affairs teams ask us.

What is agency question response software?

Software that takes a health authority letter — an FDA information request, an EMA Day 120 list of questions, a Health Canada clarification request — and carries every question to a signed answer and a response package on time. Agency Question Response adds six agents that split the letter, assign owners, find the dossier passages and past answers, draft each answer with citations, check it against earlier answers and assemble the package.

How does it draft an answer?

The dossier retriever finds the passages in the current submitted eCTD sequences and the approved past answers on the same topic for the same product. The response drafter answers every sub-part of the question in your house style, cites a dossier passage for every number and adds no data or claims beyond the dossier. The owner reviews the draft and can edit or redraft it.

How does it keep answers consistent across agencies?

The consistency checker compares every draft with every earlier answer for the same product in every market, and flags different numbers, data cuts, shelf lives or claims with a one-sentence reason and a proposed fix — such as a data-cut note. It never resolves a flag on its own; a person decides.

Which agencies and letter types does it handle?

The working solution handles FDA, EMA, Health Canada, PMDA, MHRA, TGA and Swissmedic letters — information requests, discipline review letters, Day 120 lists of questions, Day 180 lists of outstanding issues, clarification requests and screening deficiency notices. Letters arrive from the agency mailboxes or by upload.

Do people stay in control?

Yes. The agents draft and propose; only people approve or send. Each answer is reviewed by its owner and signed by the regulatory lead with an electronic signature that records the meaning, and the package is built only from signed answers and signed again before regulatory operations sends it.

Can we set our own clocks, owners and drafting rules?

Yes. Reminder days, the internal target before the agency’s date, escalation, the owner for each topic, who gives final sign-off and the drafting rules are all settings. New drafting rules can be described in plain words.

Which systems does it connect to?

Your agency mailboxes, the submitted dossier with every eCTD sequence, your past responses library, email and calendars for owner notifications, and regulatory operations, which receives the response package and eCTD sequence details.

How long does it take to go live?

The Agentic Solution Engine builds and deploys it from your requirements — your approval rules, house style, dossier and past answers — and it goes live once every quality gate has passed. We will walk you through it on one of your own past agency letters first.

Regulatory Affairs

More in this division.

All 8 solutions →

Regulatory Intelligence

Every agency change reaches the right team within hours, translated and cited.

1-min film Submission Summaries

Module 2 summaries drafted in weeks, every statement cited to its source page.

1-min film Label Change Cascade

Every core data sheet change finds each local label it touches and puts every market on a clock from day one.

1-min film

See it on
your agency letters.

We’ll run Agency Question Response on one of your past agency letters, your dossier and your past answers.

Book a demo Browse solutions

Agency Question Response

Why agency responses eat the clock

How a question moves

One FDA information request, from letter to signed answers

Every open agency clock, on one screen

The letter arrives from the FDA portal mailbox

“Split and assign” — and the agents start

Twelve questions, each with an owner and a stage

Question 7, drafted from the dossier

Every number opens at its passage

A different data cut, caught before it is sent

The regulatory lead signs the answer

The response package, built from signed answers only

Every clock met, no conflicting answer sent

Built for everyone who answers to an agency.

6 agents. Each with one job, and hard limits.

Ask about any request, answer or clock

The working solution, as it ships.

Built for regulatory work: cited, consistent, signed.

Your team’s rules, not ours

Works with the systems you already run

The difference, in numbers.

What regulatory affairs teams ask us.

More in this division.

See it onyour agency letters.

See it on
your agency letters.