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Paste the authority’s questions, reference the relevant dossier sections in your library, and Anara drafts a concise formal response to each one with cross-citations to the specific dossier section that supports it. Where a question is not fully addressed by your dossier, Anara flags the gap explicitly rather than confabulating an answer. For regulatory affairs professionals responding to EMA, FDA, or EU MDR authority questions.

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1. Describe the task

The authority’s questions arrive. Some are straightforward: the answer is in the clinical overview you already wrote. Some are harder: the question touches a gap that will need to be addressed directly rather than deflected. Anara drafts the responses in one pass. You provide the questions and reference the dossier sections already in your library. For each question, Anara locates the supporting section, drafts a formal response in regulatory language, and cross-cites the specific section where the answer is grounded. Questions the dossier does not fully address are flagged explicitly, with a note on what additional documentation would be needed. Here a regulatory consultant is responding to EMA authority questions on a generic drug’s clinical overview, working in English from an Icelandic regulatory consulting context. The questions concern pediatric dosing justification, adverse event reporting, and bioequivalence study design. 
Below are the authority's questions from the assessment report. The clinical overview and supporting sections are already in my library. Draft a formal, concise response to each question. For each response, cross-cite the specific section of the overview that contains the supporting information. If a question is not fully addressed by the dossier as it stands, write "Dossier gap" and describe what the dossier currently states and what additional documentation would address the question.

Questions:
1. Please justify the proposed dosing regimen for the pediatric population aged 6-12.
2. Provide a comparison of the adverse event profile reported in the clinical studies versus the reference medicinal product.
3. Clarify the study design rationale for the bioequivalence study conducted under fed versus fasted conditions.

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2. Give Anara context

Required context
  • The dossier sections in your library. Reference the specific folder or documents that contain the relevant clinical, regulatory, and supporting information.
  • The authority’s questions, pasted verbatim.
Optional context
  • The regulatory pathway and authority (EMA, FDA, MDR GSPR, MHRA). Anara calibrates the formal register and cross-citation format accordingly.
  • Prior correspondence from earlier assessment rounds if the questions are follow-ups to previous responses.

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3. What Anara creates

A formal response document with one response per question, each cross-citing the dossier section it draws from with a specific section reference (for example, “Clinical Overview Section 2.4.2”). Gaps are labeled explicitly and described with a short note on what would be needed to address them. The output is a working draft in regulatory prose that your team reviews, edits, and submits. The gap flags are as important as the responses: they identify which questions require additional data or analysis before the response can be finalized.

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4. Follow-up prompts

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Write the gap remediation plan

When a dossier gap has been flagged and you need to brief your team on what is needed. 
For the gap flagged on the pediatric dosing question, write a two-paragraph briefing for the clinical team describing what the authority is asking for, what the current dossier states, and what type of additional documentation or study data would address the question. Keep the language direct.

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Translate the response into a second language

When your regulatory submission requires the response in a language other than the draft language. 
Translate the formal responses we just drafted into French, maintaining the regulatory register and the cross-citation format. Do not simplify the technical terminology.

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Check a response for consistency with prior submissions

When you want to confirm that the response is consistent with how similar questions were answered in a prior submission or related product dossier. 
Compare the response we drafted to question 2 with the adverse event discussion in the prior submission for the reference medicinal product, which is already in my library. Tell me whether there are any inconsistencies in how we characterize the safety profile and flag any wording that contradicts what we previously stated.

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5. Tricks, tips, and troubleshooting

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How you word your prompt shapes what you get

The instruction “cross-cite the specific section that supports each answer” is essential. Without it, Anara writes responses that sound accurate but do not point to the dossier, making them harder to verify. Paste the authority’s questions verbatim: their exact wording signals what they want, and Anara responds to that language specifically. For GSPR responses under EU MDR, name the specific requirement (“Annex I, Section 10.1(f)”) and Anara frames the response accordingly.

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Check the output against your own understanding

Anara drafts responses grounded in what the dossier contains, not what you intended it to say. Read the cross-cited sections before finalizing: the authority will read the same sections, and any discrepancy between the response and the dossier text will be apparent. The gap flags are the most important output to review: a flagged question may have a partial answer elsewhere in the dossier that Anara did not locate if you did not reference the right folder.

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What to do with the output next

Use the draft as the starting point for your regulatory team’s review, not as the final submission. Regulatory responses carry the submitter’s professional responsibility. Edit the language, confirm the cross-citations, and address flagged gaps before sending. For multi-round assessments, save each response round as a note in your library so the prior-submission consistency check can access it in future rounds.