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 before confidential file sharing
- Response within 24 hours
- US contract with Neucite LLC
Scope your regulatory document
Send the document type, sponsor template, source-data readiness, review process and deadline. We quote writing and documented QC; eCTD compilation remains with your publishing team.
Within 24 hours
We respond to your enquiry within 24 hours. A scoped proposal follows within 24 hours of a complete brief. If a specialist discussion is needed, our first reply identifies the missing inputs and agrees the proposal date.
Within three working days
One agreed free sample per organisation is delivered within three working days after the brief, source material and any required NDA are complete.
Dates agreed before paid work
Your proposal states the fee, inputs, first-draft date, review milestones and final delivery. Work starts after you approve the scope and fee. Delivery dates depend on the document and source readiness; the 24-hour promise is for our response, not a completed manuscript.
All dollar prices on these pages are USD. Tell us your country, time zone and source/output languages; we confirm any translation, local review and invoicing requirements in the quote. Confidential files are exchanged after the NDA and secure sharing route are agreed.
What the QC record looks like
Illustrative record structure; no client data are shown.
| Check | Source | Document location | Resolution |
|---|---|---|---|
| Numerical consistency | Approved table/listing | Results paragraph | Verify value, denominator and rounding against the source. |
| Reviewer comment | Consolidated review log | Section and version | Record the change, owner and disposition. |
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, per ICH E3 and agency guidance.
- Body text from your TLFs
- Patient narratives
- Synopsis and appendices
Protocols and amendments
Study protocols and amendments built on SPIRIT 2025 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, MAA and other national submissions (PMDA, NMPA) 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 before confidential file sharing.
Receive a reply within 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 before confidential file sharing, 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.
Where client work is published
NeucitePress does not publish its writing clients' work in NeucitePress journals or books. We recommend established third-party journals, typically from Elsevier, Springer Nature and Wiley, chosen for scope and indexing. You make every submission decision, and no one can promise acceptance.
Services and guides that go with this
Your quote states the deliverables, fee, inputs and delivery milestones. We respond within 24 hours; the scoped proposal follows within 24 hours of a complete brief.
See a regulatory section written from your data
Free 2-page sample in 3 working days, NDA before confidential file sharing.
Try free: get a sample draft