Submissions and Answers, Faster.Every Claim Backed by Its Source.
Ask for a response, a section or a correction in plain words. Agents draft it into your document from approved sources as a tracked change, every claim cited, and your regulatory and medical teams accept or reject each one.
- You askIn plain words, in the chat
- It proposesEvery edit is a tracked change
- You decideAccept or reject, one by one
Response to Information Request · Application 21-4471
Question 2: Hepatic Monitoring
Explain the hepatic monitoring schedule in section 5.1 of the proposed label.
Replace:“8 weeks” with “4 weeks”
Proposed label v13 · §5.1Add:“In Study VEL-301, ALT above 3× ULN occurred in …”
Integrated Summary of Safety · §4.3A sample response to a health authority question. All names, products and numbers are made up.
Where Agents Help Your Teams
Regulatory and medical affairs teams use the same agents, the same approved sources and the same sign-off rules.
- RegulatoryHealth Authority QuestionsAnswers drafted in the document as tracked changes.
- WritingSubmission DraftingGuided templates assemble module sections, every claim cited.
- MedicalMedical InformationResponses drafted only from the sources you switch on.
- LiteratureLiterature ReviewPublications screened for safety and efficacy.
- Sign-OffReview & ApprovalMedical, legal and regulatory review in order.
Templates That Build the Section With You
A template is a guided sequence, not a file with headings. Writers enter the facts, hand the narrative steps to an agent working from your approved sources, and the module section is assembled with every claim cited.
Template Steps
- Product & IndicationProduct, strengths and indication
- Efficacy ResultsPivotal study and primary endpoint
- Safety ProfileDrafted by an agent from the ISS
- Benefit-Risk ConclusionsDrafted by an agent, every claim cited
Step 4 of 4
Benefit-Risk Conclusions
Module 2.5
Clinical Overview
1. Product and Indication
Veltrazine tablets (10 mg, 20 mg) for the treatment of hypertension in adults, NDA 21-4471.
2. Efficacy
In VEL-301 (n = 1,204), Veltrazine lowered seated systolic blood pressure by 11.2 mmHg more than placebo at Week 12.1
3. SafetyAgent
ALT above 3× ULN occurred in 1.4% of Veltrazine patients and 0.3% of placebo patients; all cases resolved after stopping.3
4. Benefit-Risk ConclusionsAgent
The reduction was consistent across subgroups.2 Hepatic risk is managed through the monitoring in section 5.1 of the label.4
Guided, Step by Step
Each step asks for what that section needs, from the product details to the benefit-risk conclusion.
Only Approved Sources
Agent Mode drafts from the knowledge base you attach, at the version you approve, and nothing else.
Consistent Across Modules
The same number reads the same way in the summary, the overview and the label.
What dose of Veltrazine should a patient with an eGFR of 25 mL/min take?
Context config
In severe renal impairment (eGFR below 30 mL/min), the recommended starting dose is 10 mg once daily.SRL-014 v3
No adjustment is needed for mild or moderate impairment, as set out in section 2.3 of the prescribing information.PI §2.3
Answers Drafted Only From the Sources You Switch On
Questions from health care professionals and patients arrive by phone, email and portal. You choose the knowledge base, tools and reviewing agent a response may draw on. With no approved source attached, nothing is drafted, and any adverse event goes straight to ThinkPV.
Approved Standard Responses
Answers come from your standard response library and the approved label, with the version shown.
Web Search Off by Policy
Medical information responses can be limited to internal, approved sources only.
Adverse Events Handed Off
A request that mentions an adverse event or complaint is sent to safety the moment it arrives.
Reviewed by the Right People, in the Right Order
Submission sections, responses and medical content each follow a route you define, through medical, legal and regulatory review. Every signature is electronic and every version is kept.
Routes You Define
Submissions, responses and medical content each follow their own route, set without code.
Electronic Signatures
Each sign-off records who signed, when, and the meaning of the signature.
An Audit Trail No One Can Edit
Every draft, edit and decision is recorded, including those made by agents.
Built for Regulated Content
ThinkTrends runs in your environment, keeps a qualified person on every decision, and keeps your data out of model training.
Your Experts Sign Every Word
Agents read, draft and cite. Regulatory and medical staff approve, and every approval is recorded under a name.
Your Data Never Trains a Model
Cases, labels, trial data and documents are used to do the work and nothing else.
Runs in Your Environment
Deploy in your cloud or data center, with patient and product data kept inside your boundary.
Validation Evidence Included
Each agent version is tested against your acceptance criteria, and the results are ready for your validation file.
21 CFR Part 11 Aligned
An audit trail no one can edit, electronic signatures with their meaning, and access by role.
Configured, Not Coded
Rules, routes, checks and thresholds are settings your administrators can read and change.
Related Modules
The platform modules these solutions are built on.
Frequently Asked Questions
Common questions about ThinkTrends Regulatory & Medical Affairs.
What does ThinkTrends offer for regulatory and medical affairs?
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ThinkTrends offers agentic document writing for regulatory and medical affairs: health authority responses, submission sections and medical information replies. Writers ask in plain words, agents draft into the document from approved sources as tracked changes with every claim cited, and your team accepts or rejects each change.
How is ThinkTrends different from ChatGPT Enterprise or Microsoft Copilot for regulatory writing?
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General-purpose assistants write from whatever they are given and edit text directly. ThinkTrends drafts only from the approved sources you attach, at the version you choose, cites every claim, proposes every edit as a tracked change and records who accepted it.
Can ThinkTrends agents submit to a health authority?
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No. Agents draft and check. Your regulatory team approves every response, and submission stays in your hands.
Which sources does a ThinkTrends draft use?
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Only the documents you approve for that work, at the version you choose: study reports, labels, safety summaries and prior submissions.
What happens when a medical information request mentions an adverse event?
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ThinkTrends sends it to your safety team, or straight into ThinkPV, as soon as it arrives, with the request attached.
Can ThinkTrends answer off-label medical information questions?
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It drafts a balanced, non-promotional response from approved sources, and a medical information specialist reviews it before it is sent.
Is our data used to train AI models?
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No. ThinkTrends uses documents only to do the work, inside your own environment. Your data is never used to train, tune or evaluate a model.