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Submit INDs in days, not months.

Scoop turns study, manufacturing, and clinical data into living regulatory submissions: every sentence traced to its source, checked for conflicts, and kept current as the science changes.

Book a demoSee how it works
IND 1437 · SCP-204 for ALS Phase 1 · Acme Bio · target Jan 14
Module 1 Administrative information 100%
Module 2 Summaries 86%
2.4 Nonclinical overview
Nov 3 · Scoop draft · 4 versions
complete
2.6.6 Toxicology written summary
Nov 5 · edited by M. Liu · 1 open comment
review needed
2.6.7 Toxicology tabulated summary
Nov 1 · Scoop draft
complete
Module 3 Quality (CMC) 71%
3.2.S Drug substance
Nov 4 · S. Chen
complete
3.2.P Drug product
Nov 6 · Scoop draft · 8 versions
2 issues
3.2.P.8 Stability
Nov 5 · J. Kumar · 2 comments
review needed
3.2.A Appendices
Not started
not started
Module 4 Nonclinical study reports 94%
4.2.3 Toxicology
Nov 2 · TX-114, TX-118 attached
complete
Module 5 Clinical 63%
5.3.5.1 Study protocol SCP-204-101
Nov 5 · Dr. Rodriguez · 1 comment
in progress
5.3.5.2 Statistical analysis plan
Nov 4 · Scoop draft · 6 versions
review needed
Open issues 3
NOAEL conflict between 2.4 and 2.6.6
Source TX-114 §5 says 15 mg/kg/day
Strength unit mismatch, 3.2.P.1 vs 2.3.P
25 mg vs 25 mg/mL
SAP v2.0 referenced but not in dossier
5.3.5.1 §9.1
Pending reviews 2
SC
2.6.6 Toxicology written summary
Requested by M. Liu · due tomorrow
JK
3.2.P.8 Stability
Requested by S. Chen · due Nov 8
Recent activity
S
Scoop proposed updates to 4 sections after TX-114 v3 upload
14 min ago
ML
Marcus resolved comment on 2.6.6 ¶4
1 hour ago
DR
Dr. Rodriguez updated starting dose rationale in 5.3.5.1
Yesterday

Built by experts from

GenentechCJ BioscienceGooglePersonaDropbox

Regulatory writing that starts from your data, not a blank page.

Scoop reads the reports, datasets, and protocols you already have, writes the modules from them, and keeps everything linked so the submission stays true to the science.

Days, not monthsFrom uploaded sources to a submission-ready draft your team reviews instead of writes.
Every sentence citedEach generated sentence links to the page, table, or value it came from.
Modules 1 to 5Administrative, summaries, CMC, nonclinical, and clinical content in one dossier.

How it works

Six steps, one connected dossier. Here is what your team sees at each one.

1

Upload what you have. Scoop maps it to the dossier.

Drop in study reports, CMC packages, protocols, datasets, and prior submissions. Scoop classifies each file, extracts the tables and values that matter, and maps everything onto the eCTD structure so you can see what is covered and what is missing before anyone writes a word.

  • PDF, DOCX, XLSX, and dataset ingestion
  • Automatic classification against Modules 1 to 5
  • Gap map: covered, partial, missing
Uploaded fileClassified asMapped to
TX-114 Final Report v3.pdf412 pages · 38 tables extractedGLP repeat-dose toxicology, rat2.42.6.62.6.74.2.3
Batch records B-05 to B-07.xlsx3 sheets · 214 valuesDrug substance batch analysis3.2.S.4.42.3.S
Protocol SCP-204-101 v2.1.docx96 pagesPhase 1 clinical protocol5.3.5.12.5
Gap mapafter ingestionModules 1, 2, 4 covered · Module 3 partial (3.2.A appendices missing) · Module 5 partial (SAP v2.0 missing)
2

Submission-ready narratives, with a citation on every sentence.

Generate module text from your sources using templates your team configures. Each sentence links back to the page, table, or value it came from, so reviewers verify claims in one click instead of hunting through appendices.

  • Sentence-level source tracing
  • Configurable templates, variables, and tables
  • Reads like regulatory writing, not a summary

2.6.6 Toxicology written summary

IND 1437 · Module 2 · Draft v5 · generated from 3 sources

Repeat-dose toxicity of SCP-204 was evaluated in a 28-day GLP study in Sprague-Dawley rats at 0, 5, 15, and 50 mg/kg/day by oral gavage.TX-114 §3.1 No treatment-related mortality occurred.TX-114 §4.1 Dose-dependent increases in ALT and AST were observed at 50 mg/kg/day in both sexes, reaching 2.1× and 1.8× control at Day 28, and were fully reversible after the 14-day recovery period.TX-114 Table 7 Minimal centrilobular hepatocellular hypertrophy was present at 50 mg/kg/day and was considered adaptive.TX-114 §4.6

The no-observed-adverse-effect level (NOAEL) was 15 mg/kg/day, corresponding to a Day 28 AUC0–24 of 14,200 ng·h/mL.TX-114 §5TK-114 Table 3 Based on body surface area conversion, the human equivalent dose is 2.4 mg/kg, supporting the proposed 10 mg starting dose with a 17-fold safety margin.5.3.5.1 §2.3

3

Run checks across the whole dossier, not one section at a time.

Automated review compares values, units, and language across modules and against source data. Conflicting NOAELs, mismatched dose units, outdated study status, and missing cross-references are flagged with the exact locations and a proposed fix.

  • Cross-module consistency checks
  • Source-to-text data verification
  • Omission and outdated-language detection
Checks · IND 1437Ran 2 min ago · 5 modules · 312 values compared
1 conflict1 unit mismatch1 outdated1 missing308 verified
2.6.6 ¶5vs 2.4 §3.2
NOAEL stated as 15 mg/kg/day in 2.6.6 but 25 mg/kg/day in the nonclinical overview. Source TX-114 §5 reports 15 mg/kg/day.
Proposed fix: update 2.4 §3.2 to 15 mg/kg/day
conflict
3.2.P.1vs 2.3.P
Strength listed as 25 mg in 3.2.P.1 and 25 mg/mL in the quality overall summary.
Proposed fix: align to batch record B-07 (25 mg per vial)
unit mismatch
2.6.7 Table 2row TX-118
Study TX-118 described as ongoing; final report was uploaded Nov 3.
Proposed fix: update status and add findings from TX-118 §5
outdated
5.3.5.1 §9.1reference
Protocol references SAP v2.0; the dossier contains SAP v1.3 only.
Proposed fix: request SAP v2.0 from biostatistics
missing
2.6.6all values
47 of 47 numeric values match their source tables.
verified
4

Comments, redlines, and approvals in one place.

Regulatory, nonclinical, CMC, and clinical reviewers work in the same document with tracked changes, threaded comments, section ownership, and approval status. Nothing lives in an email attachment.

  • Tracked changes and threaded comments
  • Section owners, reviewers, and approvers
  • Full audit trail of every edit
IND 1437 · SCP-204 for ALS Phase 1 · Acme Bio · target Jan 14
Module 1 Administrative information 100%
Module 2 Summaries 86%
2.4 Nonclinical overview
Nov 3 · Scoop draft · 4 versions
complete
2.6.6 Toxicology written summary
Nov 5 · edited by M. Liu · 1 open comment
review needed
2.6.7 Toxicology tabulated summary
Nov 1 · Scoop draft
complete
Module 3 Quality (CMC) 71%
3.2.S Drug substance
Nov 4 · S. Chen
complete
3.2.P Drug product
Nov 6 · Scoop draft · 8 versions
2 issues
3.2.P.8 Stability
Nov 5 · J. Kumar · 2 comments
review needed
3.2.A Appendices
Not started
not started
Module 4 Nonclinical study reports 94%
4.2.3 Toxicology
Nov 2 · TX-114, TX-118 attached
complete
Module 5 Clinical 63%
5.3.5.1 Study protocol SCP-204-101
Nov 5 · Dr. Rodriguez · 1 comment
in progress
5.3.5.2 Statistical analysis plan
Nov 4 · Scoop draft · 6 versions
review needed
Open issues 3
NOAEL conflict between 2.4 and 2.6.6
Source TX-114 §5 says 15 mg/kg/day
Strength unit mismatch, 3.2.P.1 vs 2.3.P
25 mg vs 25 mg/mL
SAP v2.0 referenced but not in dossier
5.3.5.1 §9.1
Pending reviews 2
SC
2.6.6 Toxicology written summary
Requested by M. Liu · due tomorrow
JK
3.2.P.8 Stability
Requested by S. Chen · due Nov 8
Recent activity
S
Scoop proposed updates to 4 sections after TX-114 v3 upload
14 min ago
ML
Marcus resolved comment on 2.6.6 ¶4
1 hour ago
DR
Dr. Rodriguez updated starting dose rationale in 5.3.5.1
Yesterday
5

When the science changes, the submission follows.

Upload a final study report or a manufacturing change and Scoop shows every section that depends on it, proposes updated text with a redline, and keeps the rest untouched. Amendments, annual reports, and the next application start from content that is already current.

  • Dependency map from sources to sections
  • Targeted regeneration with redlines
  • Version history with restore
Source updated
TX-114 Final Report v3.pdfReplaced v2 · uploaded by M. Liu · Nov 4, 9:12
Depends on this source · 4 sections
2.4 §3.2 Toxicology summary update proposed
2.6.6 ¶3, ¶5 update proposed
2.6.7 Table 2, row TX-114 update proposed
5.3.5.1 §2.3 Starting dose rationale no change
Proposed change · 2.6.6 ¶3
redline 2 values changed · everything else untouched
Dose-dependent increases in ALT and AST were observed at 50 mg/kg/day in both sexes, reaching 2.4× 2.1× and 2.0× 1.8× control at Day 28, and were fully reversible after the 14-day recovery period.TX-114 v3 Table 7
6

Hand off to publishing without reformatting.

Export finished sections as formatted DOCX or an eCTD-ready folder structure with section status and version stamps. Your existing publishing and submission process stays exactly as it is.

  • Formatted DOCX export
  • eCTD-ready structure and section status
  • Works with your document management and publishing tools
OutputVersionStatus
2.6.6 Toxicology written summary.docxformatted, citations as footnotesv5approved · M. Liu, S. Chen
m2/26-nonclin-sum/266-tox-written-summary/eCTD-ready folder with section statusv5ready for publishing
3.2.P.8 Stability.docxstability tables as DOCX tablesv3review needed

Health authority questions, answered from the same source of truth

Information requests arrive fast and repeat often. Scoop extracts each question from the agency letter, links it to the dossier sections and prior responses that answer it, assigns owners and due dates, and drafts a first response with citations. The response package compiles when the team signs off.

Question intake

Upload the letter. Each question is extracted with its discipline, module reference, and due date.

Similar question matching

See how related questions were answered before, across programs you have access to.

Source-linked drafting

First drafts cite the dossier sections, tables, and prior responses they draw from.

Workflow and tracking

Owners, reviewers, approvers, status, and deadlines in one board, with jurisdiction-specific metadata.

FDA information request · IND 1437Received Nov 2 · response due Nov 16
14questions extracted
9drafted
3in review
2approved
11 duntil due
Q1
Provide the justification for the proposed drug substance specification limit for Impurity B (0.3%).
3.2.S.4.5Batch data B-05 to B-072 similar prior responses
SC
S. ChenCMC
draft ready
Q2
Clarify the basis for selecting 15 mg/kg/day as the NOAEL in the 28-day rat study given the ALT findings.
2.6.6 ¶5TX-114 Table 71 similar prior response
ML
M. LiuNonclinical
in review
Q3
Provide the rationale for the 10 mg starting dose relative to the human equivalent dose derived from the rat NOAEL.
5.3.5.1 §2.32.6.6 ¶6
DR
Dr. RodriguezClinical
drafting
Q4
Submit stability data supporting the proposed 12-month retest period for the drug substance.
3.2.S.7Stability report B-071 similar prior response
JK
J. KumarCMC
not started

For biotech, pharma, and the CROs that serve them.

Biotech

Get from first IND to a growing pipeline without hiring a writing department.

  • Start from your existing reports and data
  • Keep source content and dossier work connected
  • Reuse content across applications

Pharma

Run multi-program regulatory writing with enterprise permissions and continuity across jurisdictions.

  • Program-level isolation and role-based access
  • Consistency checks across programs and teams
  • Fits existing publishing and DMS workflows

CROs and consultants

Deliver more client submissions with the same team, with client work kept separate and secure.

  • Segregated client workspaces
  • Faster review cycles with sponsors
  • Scale across engagements without added headcount

Built for data you cannot afford to leak

Scoop is designed to protect source data, drafts, and regulatory correspondence at every step.

Enterprise controls

  • Encryption in transit and at rest
  • SSO (SAML) and MFA
  • Role-based access by program and discipline
  • Full audit trail of edits, comments, and versions

Responsible AI

  • Zero data retention with model providers
  • No customer data used to train models
  • Drafts grounded only in your uploaded sources
  • Segregated customer environments

Questions regulatory teams ask us first.

Does this replace regulatory judgment?
No. Scoop drafts, checks, and keeps content current so your team spends its time on strategy, review, and sign-off. Every sentence is traceable to a source, which makes expert review faster, not optional.
Can we edit directly in the platform?
Yes. Edit in place with tracked changes and threaded comments. Your edits are versioned and preserved, and you can regenerate a paragraph or a section while leaving the rest of the document alone.
Will this help with amendments and annual reports?
Yes. Because the dossier stays linked to its sources, amendments, annual reports, and safety updates start from content that is already current, with the affected sections flagged for you.
Does it support submissions outside the U.S.?
Scoop is built on the CTD and eCTD structure shared by the FDA, EMA, and other ICH regions. Content can be reused across application types and jurisdictions while keeping source links intact.
Is this meant for small or large organizations?
Both. Single-asset biotechs use Scoop to produce a first IND without a writing department; multi-program pharma and CRO teams use program-level isolation, permissions, and cross-program checks.
Can this integrate with our existing document management or eCTD tools?
Yes. Bring source documents in from your repositories, keep them synced as files change, and export finished sections as DOCX or an eCTD-ready structure into your publishing process. Scoop does not submit directly to health authorities.
How accurate are the drafts?
Drafts are grounded only in the sources you upload, every sentence carries a citation, and automated checks flag conflicting values, omissions, and outdated language before a human reviews it. Expert review stays part of the process.

See Scoop on your own documents.

Tell us about your program and where the writing stands. We will walk through the platform using your reports, not a demo dataset.

Pick a time

Or write to hello@scooplabs.ai.