Health Authority Query Response Writing for Sponsors
Pubrica drafts responses to health authority questions and deficiency letters for sponsors. A response letter is written to a fixed deadline, read by a reviewer who has already raised a concern, and becomes part of the regulatory record. Common problems include answering a question that was not asked, conceding more than the question required and making commitments that have not been costed. Our regulatory medical writers keep each answer within the scope of the question, support it with evidence and check it against what you can deliver.
- Each question answered on its own terms, in the order asked, so the reviewer can close each one without searching
- Evidence assembled for each answer, including cross-references, data, literature and, where a new analysis is needed, the analysis itself
- Commitments stated precisely, because a sentence written under time pressure can become a post-approval obligation that must be funded
- Scope limited to the question, because answering more than was asked can raise questions the reviewer had not asked
- Written to your deadline, with the turnaround agreed against your response deadline
Response drafting, question by questionIncluded
Evidence assembly and cross-referencingIncluded
New analysis where a question needs itQuoted with the response
Commitment wording reviewIncluded
Submission in your nameYour responsibility
Questions → parsed → evidenced → drafted → response
- Question-by-question structure
- Evidence assembled and referenced
- Scope limited to what was asked
- Commitments checked for deliverability
- Delivered to your deadline
Deliverables
Four Core Elements of Every Health Authority Query Response
Each response addresses one set of questions to one deadline, and what was asked determines what the response covers.
From the question analysisA question about the statistical handling of dropouts is not a question about efficacy. Answering about efficacy instead invites a follow-up on the dropout handling, which had not been raised.
From the responseAs discussed in the submission, the safety profile is acceptable.See Module 2.7.4, Table 2.7.4.3 and CSR section 12.2. The rate in subjects over 65 was 8.1% against 6.9% overall; the difference is not significant and the analysis is appended. Verifiable in one step.
From the commitment reviewWe will conduct a post-marketing study to further characterise this finding.Flagged before submission: unbounded in design, population, timing and cost. Rewritten to a specific, costed and time-bound commitment the company had agreed internally.
From the scope checkThree paragraphs of unrequested context removed from a draft response. The reviewer asked about one endpoint in one subgroup; the draft discussed four.
All samples are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Four Governing Standards and Guidelines for Query Responses
Agency conventions differ, and the format of a response is particularly important in this type of regulatory writing.
Agency response conventions (FDA, EMA, MHRA, CDSCO, TGA)
Structure, numbering, cross-referencing and the expected level of detail differ by agency and procedure, so a response formatted for one agency may not meet the expectations of another.
CTD and eCTD structure (where the supporting evidence is located)
Responses cross-reference the submission. A reference that does not lead to the correct module and section costs the reviewer time and reduces confidence in the response.
Good Clinical Practice (E6(R3), not E6(R2))
Annex 1 took effect in the EU in July 2025; Annex 2, covering pragmatic and decentralised designs, follows in January 2027.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Governs how each document is drafted, reviewed, version-controlled and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to evidence and to a responsible individual. Our specialists therefore treat source traceability as more important than speed, and every statement in a document must be supported by a traceable source.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI tools are usually reported by the companies that sell them.
For this reason, Pubrica does not quote an accuracy figure of its own, as it would carry the same conflict of interest. We tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our Health Authority Query Response Writing Process Works
Analysing the questions is the main part of the work, and drafting begins once everyone agrees what is being asked.
Question analysis
We read each question to establish what is being asked and what would satisfy it, and record the evidence position as available, requiring analysis, or not available.
Evidence assembly
We gather data, cross-references and literature for each question, and scope and commission any new analysis early.
Drafting and commitment review
Each answer is written in the agency’s conventions, and every commitment is reviewed for deliverability before it is included.
Review cycles within the deadline
We consolidate your regulatory, clinical and statistical comments in each cycle and work to the response deadline rather than a standard turnaround.
Our Experts
Our Regulatory Writing Team
The same named team of regulatory specialists works on your project from scoping to delivery, and your project coordinator introduces each member before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. The expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
Two Health Authority Query Response Service Packages
Cost depends on the number of questions, the amount of new analysis required and the length of the response period.
Query response
Sponsors with agency questions or a deficiency letter
Quoted per projectOn question count and analysis required
Delivery To your deadline
- ✓Question-by-question analysis and evidence position
- ✓Drafted in the agency’s conventions
- ✓Cross-references verified to module and section
- ✓Commitments reviewed for deliverability
- ✓Review cycles completed within the response deadline
Please send the letter on the day you receive it. The deadline is fixed, and the first two days are often lost to internal circulation.
Deliverables Request a quoteBriefing book and meeting package
Pre-submission and scientific advice meetings
Quoted per projectOn meeting type and question count
Delivery By scope
- ✓Briefing document with background and position
- ✓Questions framed to obtain clear advice
- ✓Supporting data and analysis assembled
- ✓Backgrounders for the team
- ✓Post-meeting minutes drafted from your notes
The questions you ask determine the advice you receive, so framing them carefully is the most valuable part of the package.
Deliverables Request a quoteSend us the letter and we will provide a free question analysis within two business days, setting out what each question asks, what would satisfy it and where the evidence does not yet exist.
FAQs
Health Authority Query Response FAQs
If your question is not answered here, ask an expert. No quote is required.
We work to your deadline. Response periods are fixed and short, so the turnaround is agreed against your deadline rather than offered as a standard figure.
The main constraint is usually whether a question needs new analysis rather than the drafting itself. We establish this in the first two days, which is why it is important to send the letter immediately.
This is established in the question analysis on the first or second day, so the analysis can be commissioned in parallel rather than identified late.
We can carry out the analysis, including analysis of your locked dataset, pooled analyses and literature-based support, or work alongside the team that does.
A commitment in a response becomes a post-approval obligation. A sentence written under time pressure can create a study that must be designed, funded and delivered over several years.
We flag every commitment before it is included, with its likely cost and owner. Some commitments are worth making, but each should be a deliberate decision.
No. Volunteering additional analysis or reassurance usually leads to further questions and extends the review.
Answer what was asked completely and verifiably. Where you believe the reviewer has misunderstood something, address it directly rather than expanding the scope.
No. The response is prepared for your signature and submitted by you or your regulatory function, in your name.
We prepare, cross-check and format the response; you approve and submit it. It becomes part of your regulatory record and must be issued in your name.
Related Services
Related Regulatory Writing Services
A query response draws on the whole submission and often requires new analysis.
1THE ORIGINAL SUBMISSIONwhere the evidence is located
Regulatory writingCTD modules, dossiers and submissions. Clinical study reportTo ICH E3, with narratives.2NEW ANALYSISanalysis and evidence
BiostatisticsAnalysis against your locked dataset. Systematic reviewLiterature-based support, documented.3FOR DEVICESdevice documentation
Clinical evaluation reportEU MDR Annex XIV. Clinical trial supportProtocol, SAP and disclosure.Request a Free Question Analysis of Your Health Authority Letter
We will provide a free question analysis within two business days, setting out what each question asks, what would satisfy it and where the evidence does not yet exist.