Answer regulator questions
Draft a formal response to a regulatory authority question from your dossier.
Paste the authority's questions, point Anara at the dossier sections in your library, and it drafts a formal response to each one with a cross-citation to the section that supports it. Where the dossier does not fully answer a question, it flags the gap instead of inventing an answer.
Prompt
A regulatory consultant answers EMA questions on a generic drug's clinical overview.
Prompt
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.What to add to your library
- Required: the dossier sections, with the specific folder or documents referenced in the prompt.
- Required: the authority's questions, pasted verbatim.
- Optional: the pathway and authority, such as EMA, FDA, MDR GSPR, or MHRA, which sets the register and cross-citation format.
What you get
- One formal response per question, in regulatory prose.
- A specific section reference behind each response, for example "Clinical Overview Section 2.4.2."
- Explicit gap labels with a short note on what would be needed to close each one.
Follow-ups
Brief the team on a flagged gap.
Prompt
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.Check a response against a prior submission.
Prompt
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.Tips
- Ask for a cross-citation on every answer, or the responses read well but cannot be verified.
- Paste the questions verbatim. Their exact wording is what Anara responds to.
- For GSPR responses under EU MDR, name the requirement, for example "Annex I, Section 10.1(f)."
- Read the cross-cited sections before finalizing, and treat the gap flags as the output to review first.