Vespper

What do they actually do

Vespper runs a web-based AI assistant for life‑science regulatory work. It helps regulatory professionals draft regulated documents (e.g., SOPs, IND/IDE/510(k) sections, clinical study reports, informed consent forms), search internal files, and query public regulatory databases such as FDA 510(k), MAUDE, EMA, PubMed, and more. Answers come back with citations to the underlying sources and a visible reasoning trace so reviewers can verify claims before accepting changes Vespper homepage YC company page.

A typical workflow is: upload/connect internal regulatory artifacts for ingestion and indexing; open the editor to apply a template and generate a first draft with inline citations; ask natural‑language questions about regulations, prior submissions or literature; and extract structured tables from study reports (e.g., adverse events, endpoints). The product emphasizes review and compliance controls (citations, step‑by‑step reasoning, user confirmation) to support auditable, regulated workflows Vespper homepage.

The app is gated (login plus “book a demo”), and the team is operating an early commercial motion with founder‑led demos/pilots and industry‑conference outreach. For security‑sensitive buyers, Vespper offers enterprise deployment options (self‑hosted/VPC/on‑prem) and end‑to‑end encryption to keep regulatory data within controlled infrastructure Vespper homepage YC company page founder LinkedIn updates.

Who are their target customer(s)

• Regulatory writers at pharma/biotech/med‑tech companies: They spend time drafting repetitive sections and searching prior submissions or literature to cite, and need outputs that are clearly traceable to source documents for review Vespper homepage.
• Heads of regulatory affairs or regulatory managers: They need to shorten review cycles while maintaining a defensible audit trail and minimizing the risk of inaccurate or untraceable claims in filings Vespper homepage.
• Quality assurance and compliance officers: They must validate documents and maintain records for inspections; every claim must be backed by a verifiable source, with reviewable/versioned changes, and sensitive IP kept within approved infrastructure Vespper homepage.
• Clinical operations staff and study authors: They need to extract adverse‑event tables, endpoints and summaries from study reports and run literature/clinical‑trials searches; manual extraction and searches slow report generation and reviewer sign‑off Vespper homepage.
• Medical device regulatory specialists (510(k)/safety reporting): They need fast searches of FDA/MAUDE/EMA records and predicate devices, worry about missing precedents, and prefer secure or on‑prem deployments to avoid exposing proprietary device information Vespper homepage founder updates.

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

• First 10: Founder‑led, high‑touch pilots from existing demo leads (conferences, YC intros), focused on a single document type (e.g., SOP or 510(k) section) that yields an auditable draft reviewers can sign off on; reduce procurement friction via on‑prem/VPC installs and a validation pack Vespper homepage founder updates.
• First 50: Turn pilot wins into case studies and referrals, run targeted outbound to similar regulatory teams, and partner with regulatory consultancies/CROs; host hands‑on workshops and publish template libraries and validation guides to speed buyer sign‑off Vespper homepage.
• First 100: Stand up a small enterprise sales team (SDR/AE/CS), productize secure deployments and onboarding (self‑hosted/VPC images, standard validation docs), and ship integrations to common QMS/document systems; add channel partnerships with regulatory software vendors and consulting firms to run low‑cost pilots and expand seats.

What is the rough total addressable market

Top-down context:

Analyst estimates put life‑science Regulatory Information Management (RIM) / regulatory software around USD 2.0–2.3B in 2023–2024, with expected double‑digit growth. Vespper fits within this category via regulated document drafting, search, and citation‑grounding GMI Insights Grand View Research.

Bottom-up calculation:

RAPS counts 124,436 regulatory professionals worldwide. If priced at ~$6,000 per user per year, the user‑based TAM is ~USD 746M annually; at ~$20,000 per user per year (enterprise/on‑prem), it’s ~USD 2.49B. These scenarios are illustrative and map to how a per‑seat or team‑based model could scale RAPS.

Assumptions:

• Uses global regulatory headcount from RAPS as a proxy for potential buyers, acknowledging not all are in life sciences or immediate targets.
• Assumes mid‑enterprise pricing of ~$6,000/user/year (and higher for VPC/on‑prem) as a reasonable analog given regulated software buying patterns.
• Excludes broader non‑RIM compliance categories from the top‑down TAM to avoid overstating near‑term addressability.

Who are some of their notable competitors

• Veeva (Vault RIM / Veeva AI): Incumbent enterprise platform for regulatory information and document management; buyers already use Vault for submissions, approvals, and versioned records. Veeva is adding AI agents that surface, compare, and summarize regulatory content inside validated workflows, competing on integrations, auditability, and enterprise readiness Veeva RIM Veeva AI.
• Clarivate (Cortellis Regulatory Intelligence): Commercial regulatory‑intelligence database with an AI assistant for conversational search, summarization, and document comparison. Competes on breadth and curation of regulatory sources that teams rely on for strategy and citations Cortellis Regulatory Intelligence.
• IQVIA: Large life‑sciences provider bundling regulatory intelligence, validated RIM tools, AI, and services. Competes by offering end‑to‑end regulatory workstreams (monitoring, drafting, validation) through a single vendor IQVIA Regulatory Intelligence IQVIA AI.
• Elicit (academic/research AI): AI assistant for literature and clinical‑trials search with citations. It substitutes for research/evidence‑gathering but lacks built‑in RIM integrations, audit trails, and deployment/security controls common in regulated RA/QA workflows Elicit.
• DIY RAG stacks (e.g., LlamaIndex + vector DB): Engineering teams can build internal, citation‑backed assistants by indexing regulatory documents and public databases. This maximizes control and security but requires engineering effort, ongoing tuning, and regulatory validation (e.g., with LlamaIndex and vector DBs like Weaviate) LlamaIndex docs Weaviate + LlamaIndex.