Soma
Founding cohort · 3 organisations

Regulatory review becomes confirmation, not correction.

The intelligence platform for biotech organisations — built for European regulatory requirements from the ground up.

Built by Rosa Garcia-Verdugo, PhD — five years working with commercial and scientific teams at PromoCell, nCardia, Temedica, Evotec, and Qiagen.

The problem

Accurate science. Uncoordinated communication.
Every function — a different version of the same story.

Science without alignment

Scientists communicate using their most current data — without reference to approved messaging frameworks. Accurate science, uncoordinated communication.

Marketing without current evidence

Campaigns are built from an evidence snapshot that may be months behind what the scientific team now knows. Compliant — but outdated.

Sales without visibility

Field intelligence disappears into call notes; reps quote yesterday’s data.

Regulatory without reach

Approval status lives in Regulatory’s head, not in Marketing’s deck.

This is not a failure of any team. It is a structural absence — no shared infrastructure for keeping a growing organisation’s knowledge current, synthesised, and aligned.

Why Soma is different

Built for this problem
Not adapted from a generic tool

Off-the-shelf AI has no awareness of your approved claims or what’s confidential. In a regulated industry, that’s a liability.

Ready from day one — no upload campaigns.

Soma reads what your organisation already has. The knowledge base is populated automatically on deployment — not through upload campaigns that never get completed.

Intelligence that compounds

Every approved content piece joins the knowledge base automatically. Every approval makes the next generation more aligned. The system improves with every use — and that improvement belongs only to you.

Regulatory built in, not bolted on

Regulatory guidelines inform every generation. Content arrives at review already shaped by the rules — so the review is confirmation, not correction.

Built for European biotech — GDPR compliance is architecture, not an afterthought

Documents stay on your network

Raw documents are processed locally in the on-premise deployment model. Only extracted text travels to Soma.

Data residency in Frankfurt

All data stored in europe-west3 by default. Your data never leaves the EU.

Personal data stripped at ingestion

Email content is automatically stripped of personal data before any cloud write. Privacy by design.

Data processing agreements

DPAs ready to sign. Full compliance documentation provided at onboarding — not on request.

Who it’s for

Built for growth-stage biotech

Organisations complex enough to feel the fragmentation problem — but without the infrastructure, or the budget, for enterprise-scale tooling.

Organisation profile

Series A through Series C

50–500 employees. Big enough to feel the fragmentation. Small enough that no one’s solved it yet. European regulatory context — EMA, GDPR — built into the architecture.

Therapeutic focus

Where evidence velocity matters most

  • Cell and gene therapy
  • Precision oncology
  • Immunology
  • Digital health and SaMD
  • Research tools

Where the evidence base moves quickly, the audience is scientifically expert, and narrative inconsistency is immediately costly.

Economic buyer

CMO · VP Medical Affairs · Head of Regulatory · CSO · CEO

The product addresses pain across all functions, but the case is made at leadership level — coherent scientific narrative, faster regulatory cycles, and field intelligence that informs strategy rather than disappearing into call notes.

One knowledge base

One knowledge base. Five functions feeding and querying it.

Five roles share a single source of truth. Each contributes what it owns and queries what it needs — through an interface tuned to its judgment.

Scientific

Adds literature, queries evidence.

Regulatory

Adds approved claims, reviews drafts.

Medical Affairs

Adds KOL notes, queries safety.

Marketing

Creates content from approved sources.

Sales

Adds field intelligence, queries call prep.

How it works

One knowledge base. Every function. Always current.

Connects to what you already have. Keeps it current. Gives every team a shared intelligence layer.

  1. Soma reads what you already have — on day one.

    On deployment, Soma connects to your existing document storage and populates the knowledge base automatically. No upload campaigns. No onboarding marathons. Your organisation’s knowledge is already there — Soma makes it queryable from the first day.

    Soma admin dashboard
    Soma admin dashboard: knowledge sources (Google Drive, SharePoint, Company website) with sync status, six top-level metrics (documents indexed, pending review, approved content, last sync, brand templates, active users), the Company knowledge pack with mission/product/regulatory/brand/style toggles, and team-and-access cards for team members, disclosure flags, similarity flags, and sign-in security.
  2. Each function contributes its own evidence type and queries the rest.

    Scientific data, regulatory constraints, KOL insights, approved messaging, field intelligence — all of it flows into one shared knowledge base. Every team queries the same current picture, through an AI interface tuned to their role and judgment.

    Soma regulatory intelligence query
    Soma regulatory intelligence query, annotated: numbered callouts highlight evidence-conflict detection, auto-surfaced key stats, claim status labels (approved / market restricted) and the top-evidence panel ranked by authority tier.
    • Evidence conflict detection — AI flags disagreements across sources
    • Knowledge Base sidebar — every doc indexed, disclosure-labelled
    • Structured response with cited approved claims — full traceability
    • Every claim status-labelled: APPROVED / RESTRICTED / INTERNAL
  3. Every deliverable, drafted from your full knowledge base.

    When any function needs a deliverable — a briefing note, a one-pager, a congress abstract, a campaign brief — Soma drafts it using the full knowledge base, your brand identity, and approved content as style reference. The draft arrives already aligned. Users edit and finalise.

    Soma create / edit view
    Soma create / edit view, annotated: numbered callouts highlight role-specific output templates, source-transparency on excluded sources, automatic compliance pre-check and one-click routing to MLR or scientific review.
    • Role-specific output formats — call prep / one-pager / KOL brief
    • Approved-claim language drafted, cited inline with provenance
    • Sources, drafts and confidence-score tabs in the right panel
    • One-click routing — submit for MLR or peer-review first
  4. Regulatory closes the loop in minutes, not weeks.

    Content for external audiences goes through a lightweight in-app review workflow. Regulatory sees exactly which sources informed which claims. Because Soma applied regulatory guidelines during generation, most reviews are approval, not revision.

    Soma regulatory review
    Soma regulatory review queue, annotated: numbered callouts highlight overdue-first review queue by function, embedded IMPORTANT callouts, AI pre-review flags, the MLR checklist and the single approve / needs-revision decision action.
    • Review queue with overdue flags — oldest-first, by function
    • AI pre-review — flags and checks before the reviewer opens the doc
    • Draft body inline with track-changes — full audit trail
    • Cited sources with authority tier — full provenance per claim
    • Approve or request revision — single decision, fully audited

See it in motion

One flow: query, create, review.

A short walkthrough of the actual product — the same flow you just read about, live.

No sound — a silent ~60-second walkthrough. Prefer to read? The same query → create → review flow, step by step.

This is the product today — pre-launch, built together with our founding cohort.

Apply to be a design partner
Rosa Garcia-Verdugo, PhD — founder of Soma

About the founder

Rosa Garcia-Verdugo, PhD

Founder · somaintegral.io · Heidelberg, Germany

Five years working with the commercial and scientific teams at PromoCell, nCardia, Temedica, Evotec, and Qiagen — observing the same fragmentation pattern across every size, stage, and function. Soma is the infrastructure I wished existed. PhD in biology, €1.2M in European research grants, and deep expertise in science communication, medical writing, regulatory-aware content, and biotech marketing strategy.

Five years of freelance & consulting experience with

  • PromoCell logo
  • nCardia logo
  • Temedica logo
  • Evotec logo
  • Qiagen logo

Design partner programme

Shape the product
Before anyone else has it

Building now. Working demo in Q3 2026 — design partners get early access and shape what gets built in what order. We are forming a founding cohort of three organisations whose real use cases define the product.

Who we’re looking for

  • European biotech, roughly 20–200 people
  • Post-Series A or equivalent — with an in-house commercial, medical or regulatory team
  • A real, current workflow you want Soma to take on

What we ask of partners

  • A few working sessions to map your real workflows
  • Hands-on use of early builds in a real operational context
  • Honest feedback — what works, what doesn’t, what’s missing

Early access to the prototype

Use Soma in a real operational context before it is available to anyone else.

Direct input into product direction

Your use case, your workflows, and your priorities shape what gets built and in what order.

Preferential commercial terms at launch

Design partners receive founding pricing that reflects their role in shaping the product.

A product built around your actual problem

Soma’s roadmap is a list of your problems — in priority order.

Apply to be a design partner

A short application — Rosa reads each one personally and replies within a few days.

We review founding-cohort applications on a rolling basis and close the cohort once the seats are filled.

We will not share your information with third parties.

Not ready to apply yet? You can also send us a message and we’ll come back to you.

Apply to be a design partner