Regulatory documents written to structure and checked against your data
Clinical study reports, protocols, investigator brochures, CTD clinical summaries and lay summaries, with a QC record for every number.
- Free sample draft in 3 working days
- 3 review rounds included
- NDA signed the same day
- Proposal within 24 hours
- US contract with Neucite LLC
Clinical and regulatory documents, in your templates
We work in sponsor or CRO templates and deliver submission-ready files to your regulatory and publishing teams.
Clinical study reports
Full, abbreviated and synoptic CSRs to ICH E3.
- Body text from your TLFs
- Patient narratives
- Synopsis and appendices
Protocols and amendments
Study protocols and amendments built on SPIRIT and ICH GCP.
- Protocol synopsis and full protocol
- Amendments with change summaries
- Informed consent support documents
Investigator brochures
New IBs and annual updates.
- Nonclinical and clinical sections
- Reference safety information
- Annual update cycle
CTD clinical summaries
Module 2.5 clinical overview and 2.7 clinical summaries to ICH M4E.
- 2.5 clinical overview
- 2.7.1 to 2.7.4 summaries
- Cross-study integration
Submission support
Clinical sections and responses for IND, NDA, BLA and MAA work.
- Briefing documents
- Responses to agency questions
- Clinical sections of submissions
Lay summaries
Trial results for the public, including EU Clinical Trials Regulation lay summaries.
- EU CTR lay summaries
- Plain-language trial results
- Readability-tested wording
A QC record for every document
Regulatory writing fails on numbers and consistency. Every document we deliver comes with the record that shows it was checked.
- Data QC: every number in the text traced to its table, listing or figure, with the check recorded
- Template compliance: sponsor or CRO template and ICH structure followed section by section
- Cross-document consistency: CSR, IB, protocol and summaries checked against each other
- Style and terminology: sponsor style guide, abbreviation list and MedDRA terms applied
- Comment resolution log: every reviewer comment and how it was resolved, by round
- Version history: dated versions with tracked changes for your document management system
A 2-page regulatory sample from your own data
Before you sign, see how we write and QC on your study. We draft a short section from your tables under NDA.
- A CSR results section from your TLFs
- A section of a 2.7 clinical summary
- A protocol synopsis from your concept sheet
- A lay summary of a completed trial
What arrives with the sample
- The drafted section in your template
- Its data QC record
- A note on what the full document needs
- Delivered in 3 working days, under NDA
From brief to delivery
Fixed scope, fixed fee and dates agreed in writing before work starts.
Send the brief
Tell us the deliverable, target and deadline. We sign your NDA the same day.
Get a proposal in 24 hours
Scope, fee, your named writer and dated milestones.
Write and review
Three review rounds included. Fixes for our own errors are always free.
Deliver with the record
Final files plus the checklist, logs and QC record for the job.
Questions we are asked first
Do you work in our templates?
Yes. We write in your sponsor or CRO templates and follow your style guide. If you have none, we use ICH-structured templates.
Do you publish the eCTD?
No. We deliver submission-ready Word files to your regulatory publishing team or vendor, who compile the eCTD.
How do you handle confidential data?
We sign your NDA the same day, access is limited to the named project team, and we follow your data-handling instructions.
Do you also write HEOR and market access documents?
Yes. We write value dossiers, budget impact model reports and payer materials alongside the clinical documents.
Can you take overflow work from our team?
Yes. Agencies and CROs reserve writer hours by the month, delivered under their own brand.
How many review rounds are included?
Three rounds are included in every fixed-fee document, and corrections for errors on our side are always free.
See a regulatory section written from your data
Free 2-page sample in 3 working days, NDA the same day.
Try free: get a sample draft