Scoop

What do they actually do

Scoop turns a biotech’s existing study, manufacturing and support documents into draft IND submission text, links each sentence back to its source, flags inconsistencies, and updates affected sections as new data arrives. Today they focus on drafting Module 2 and Module 3 narratives for INDs with full traceability and issue detection, delivered via demos and enterprise pilots to regulatory teams and CROs/consultants scooplabs.ai, YC company page.

Near term, they aim to make INDs a continuously updated workspace (rather than one‑off assemblies) and then expand the same approach to amendments, annual reports and other regions/filing types. The company is early stage and operating via “Book a Demo” enterprise sales with a two‑person founding team scooplabs.ai, YC company page.

Who are their target customer(s)

• Regulatory affairs lead at a small biotech: Manually assembles INDs from reports and spreadsheets, spends time tracking which source supports each claim, and often relies on costly consultants. The process is slow and error‑prone.
• Project manager at a CRO or regulatory consultancy: Must prepare multiple client INDs with limited staff, battling copy‑paste, inconsistent templates, and no fast way to show reviewers the provenance of each sentence.
• CMC or clinical scientist authoring technical sections: Values and descriptions drift between sections; new lab or trial data forces frequent rework with no easy way to see which text needs updating.
• VP of Regulatory or Head of R&D at an emerging biotech: Needs to shorten time and cost to file and amend submissions, reduce risk of regulatory errors, and cut external vendor fees while keeping submissions current as data changes.
• Quality/compliance officer: Must maintain audit trails and provenance. Struggles to prove which source supports each claim and to keep a single “living” submission synchronized as documents change.

How would they acquire their first 10, 50, and 100 customers

• First 10: Founder‑led outreach to seed‑stage biotechs, YC/accelerator portfolios, and boutique CROs with imminent INDs; offer a free or discounted, time‑boxed pilot that ingests documents and delivers Module 2/3 drafts with traceability, with hands‑on training and measured time/error reductions to convert to paid pilots.
• First 50: Standardize a packaged “IND in X weeks” pilot (scope, deliverables, success metrics) and add an early BD hire to run targeted outbound and joint webinars with reference customers, using two to three public case studies and quantified ROI to drive inbound and shorten cycles.
• First 100: Scale with enterprise sales and CS, reseller partnerships with mid‑tier CROs/consultancies, and documented integrations for DMS/eCTD workflows; drive volume via conferences, workshops, audit‑ready templates/ROI tools, and a partner certification to enable referrals with less hand‑holding.

What is the rough total addressable market

Top-down context:

Regulatory Information Management (RIM) software is a multi‑billion dollar category. Estimates place the global RIM market at roughly $2.3B in 2024, growing to ~$4.1B by 2030, indicating substantial spend on regulatory content, publishing and submissions tooling Grand View Research, Research & Markets.

Bottom-up calculation:

In the U.S., FDA receives on the order of ~1,500 new INDs per year. If Scoop targets ~60% of new IND programs at small/mid biotechs via sponsors and CROs, with an average $75k software+support price per IND‑year for Module 2/3 drafting and maintenance, the initial wedge TAM is roughly ~$68M/year (1,500 × 60% × $75k) PubMed, Cardinal Health.

Assumptions:

• Focus on U.S. INDs only; excludes EU CTAs/ROW equivalents and excludes post‑approval filings.
• Average annual contract value of ~$75k per IND program covering Module 2/3 drafting, traceability and ongoing updates.
• Serviceable share is ~60% of new INDs (small/mid biotechs and CROs), not counting legacy active IND maintenance or larger pharma.

Who are some of their notable competitors

• Veeva Vault Submissions: Incumbent regulatory content management and submissions suite (including publishing) used by many large biopharmas; increasingly adds automation/AI across authoring and assembly Veeva.
• ArisGlobal LifeSphere Regulatory: End‑to‑end regulatory platform (RIM, Documents, Submissions, Labeling) with GenAI/LLM features; broad footprint across life sciences and CROs ArisGlobal.
• LORENZ docuBridge: Widely used eCTD compilation/publishing system for assembling and managing submissions; known with both industry and agencies, with eCTD 4.0 support LORENZ.
• Ennov Dossier/RIM: Regulatory dossier management and publishing integrated with Ennov’s RIM/Doc suite; supports eCTD 4.0 and dossier assembly Ennov.
• Freyr Digital (SUBMIT PRO): eCTD publishing software and global submission services used by smaller biopharma and consultancies to compile and submit IND/NDA/BLA and global equivalents Freyr.