Scoop GTM brain

Scoop helps biotech regulatory teams draft and maintain IND submissions from study, clinical and manufacturing documents.

category

AI regulatory submission authoring

market profile

  • text: IND preparation brings together clinical, nonclinical and manufacturing evidence across contractors and internal teams.
  • text: Life sciences companies are adopting AI to accelerate labor-intensive regulatory document preparation.

personas

  • title: Head of regulatory affairs at a biotech
    pains:
    • IND deadlines depend on reconciling reports across external and internal teams
    • Inconsistent values across modules create review and rework
  • title: Regulatory medical writer or CRO lead
    pains:
    • Finding source evidence for every claim takes time
    • Revisions to studies force updates across a dossier
  • title: CMC program lead
    pains:
    • Manufacturing packages and stability data must be assembled into consistent Module 3 content
    • Missing or outdated inputs jeopardize the submission schedule

icp

  • text: Preclinical and early clinical biotech sponsors preparing INDs and approaching first-in-human studies.
  • text: CROs and regulatory consultancies supporting biotech sponsors with IND preparation; company size is not specified.

message pillars

  • text: Shorten preparation from months to days.
  • text: Make review traceable to the source material.
  • text: Keep a dossier current as evidence changes.

objections

  • objection: How can we verify generated regulatory statements?
    response: The platform links generated sentences to source pages, tables or values, enabling a qualified reviewer to check them.
  • objection: Will it handle our evolving CMC and study data?
    response: Evaluate ingestion, source mapping and change tracking on representative packages before committing.
  • objection: Does automation remove our regulatory responsibilities?
    response: The site describes drafts for the team to review; the sponsor should retain expert oversight and submission accountability.

competitors

  • name: Tehistark AutoDossier
    website: https://www.tehistark.com/
    why: Generates IND and other regulatory dossiers from study data.
  • name: Sanai
    website: https://sanai.ai/solutions/regulatory-submissions
    why: Offers AI authoring for IND and other regulatory submissions.
  • name: Angelonia AI
    website: https://www.angelonia.ai/
    why: Offers life sciences regulatory documentation and IND submission tools.

keywords

  • IND submission software
  • AI regulatory writing biotech
  • eCTD IND authoring
  • CMC module 3 automation
  • nonclinical overview drafting
  • IND document traceability

voice

  • precise
  • scientific
  • outcome-oriented

signals

  • text: Biotech announces an IND-enabling study or targets a first-in-human trial.
  • text: Sponsor is consolidating CMC and toxicology packages from multiple external partners.

stack

  • eCTD
  • PDF
  • DOCX
  • XLSX

pricing

model: unknown

motion

sales_led

channels

  • YC directory
  • demo requests

confidence

medium

Founders

  • name: Vincent Park
    title: Founder/CEO
    role: CEO
    bio: CEO and Co-founder @ Scoop. Previously at Persona and Dropbox. Working on Scoop to help speed up drug trials, starting with IND filings, to help companies bring life-saving treatments to market faster.
  • name: Jay Kwon
    title: Founder/CTO
    role: CTO
    bio: Co-founder and CTO @ Scoop. Ex-Google Search applied AI (Gemini CoT), supported IND and Phase III clinical trial design for ALS therapy at Corestem, prev at Genentech and CJ Bioscience. MS in Computer Science and Biotechnology from Penn.

Back to YC companies