Skip to main content

Land small, prove fast, expand - Explore the Squirro AI Agent Catalog – Here

Book a Demo
Biotech · Drug Development

Developing a Drug Costs $2B. Every Week Lost Is Unrecoverable.

Ninety percent of preclinical candidates never reach patients. The ones that do make it on tight timelines, with no margin for regulatory delays. The Pre-clinical Regulatory Agent gives your team that edge.
Save Money
Deploy in 4-8 Weeks
Medium Effort

Trusted by Industry Leaders

Zwickroell Henkel Siemens OCBC Bank Candriam Bertelsmann IDB Invest Security Benefit
swiss-rocket 1

"Our goal is to make Swiss Rockets a fully AI-empowered organization, Squirro’s technology allows us to transform how we manage knowledge, make decisions, and scale innovation – faster, smarter, and more efficiently." 

- Dr. Vladimir Cmiljanovic, Founder and CEO of Swiss Rockets AG.

Read the Full Story

How it works

From Regulatory Question To Cited, Defensible Answer.

Preclinical programs fail on timelines as often as on science. Guidance changes and nobody catches it. Freedom-to-operate analyses stall because patent databases are fragmented and deliberately opaque. Study reports wait on writing expertise most teams are stretched to provide. None of these delays are inevitable — they are information problems. Squirro connects agency guidance, patent repositories, and internal study data into one source-traceable answer layer built for regulatory and IP teams.

01

QUESTION

Question submitted in plain language

No Boolean logic, no database syntax. Asked the way a regulatory professional would ask a colleague — understood with the same domain awareness.

Squirro understood
  • Jurisdiction FDA · US
  • Framework ICH M3(R2) · S9
  • Topic First-in-human · oncology
  • Document type Agency guidance + internal study reports
02

CONNECTIONS

Every connected source searched simultaneously

Internal documents, FDA and EMA guidance, ICH guidelines, ISO standards, and patent repositories queried in parallel. The regulatory knowledge graph surfaces connections manual search would miss.

Regulatory Knowledge Graph FDA · EMA · ICH · ISO · patent repositories
IND query · oncology
Patent repositories
Study data
FDA · EMA guidance
ICH · ISO
Found Lead compound from a 2022 internal tox study appears in a recent EPO patent — flagged for freedom-to-operate before filing
03

RESPONSE

Cited answer returned with source highlighting

Exact document, section, and clause returned with every answer. Every output defensible to a regulatory agency or a partner due-diligence team — no hallucinations, no undefendable claims.

R. Okafor · Regulatory Affairs
What nonclinical studies does FDA require before a first-in-human oncology trial?
Squirro
Squirro
Under ICH S9, an oncology program in patients with advanced cancer can proceed on a reduced nonclinical package: repeat-dose toxicity in two species, genotoxicity, and safety pharmacology endpoints integrated into the toxicity studies. Standalone carcinogenicity studies are not required to support these trials. ICH S9 §2 · ICH M3(R2) · FDA Guidance (2010)
✓ Cited · source-traceable
04

MONITORING

Changes flagged before they affect active submissions

Regulatory guidance monitored continuously. When FDA or EMA updates guidance relevant to an active project, the team is alerted — with an assessment of which submissions are affected.

Regulatory Change Watch Live · 6 active submissions
  • IND · Oncology · ARC-201 FDA revises ICH S9 dosing guidance · affects Module 4 · FDA Assess impact →
  • IMPD · EMA · ARC-118 EMA updates first-in-human risk guidance · new safety section · EMA Assess impact →
  • IND · ARC-334 ICH M3(R2) Q&A addendum published · clarification · ICH Assess impact →
  • Device file · ARC-090 ISO 10993-1 biocompatibility revision · under review · ISO Assess impact →
2 changes affect active submissions · flagged before they reach a filing deadline

Evidence in Action

Watch Squirro Handle a
Pre-Clinical Regulatory Question End to End.

Loading the Squirro assistant…
Integrations

Connect Seamlessly with Your Existing Data

Break down data silos and integrate all of your existing data, creating a single source of truth. 
connectors-hp-crop

 

Your Expansion Path

Start Here. Scale Across your Team

Each stage adds capability depth and coverage breadth.

  1. 01 To start

    Pre-clinical regulatory agent

    Regulatory knowledge graph, study report generation, patent search and summarization, source-cited answers. Secure platform. Early access deployments underway.

  2. 02 Next

    SOP compliance gap analysis

    Internal SOPs compared against current regulatory standards – gaps identified before the agency does, remediation cited to the relevant guidance.

  3. 03 Next

    Multi-jurisdiction compliance view

    FDA, EMA, ICH, and PMDA requirements compared in a single view – harmonization opportunities identified, jurisdiction-specific divergences flagged before submission.

  4. 04 Vision

    Full regulatory intelligence platform

    Guidance tracking, submission generation, FTO analysis, and compliance monitoring – compounding with every project, every submission, every update your team processes.

Our Platform

Connect Once, Govern Once, Reuse Everywhere.

Most enterprises rebuild the same plumbing for every AI project — connectors, governance, retrieval, audit. Squirro builds it once. You extend it.

dSquirro Platform Copy-1 1

One Platform. Limitless Workflows. Ready to Deploy.

Ready to deploy

Start Where the Friction Is. 

Regulatory guidance tracking, patent FTO analysis, and submission document preparation each create friction differently across every Biotech pipeline – so we are mapping the most strategic path to value with a small number of regulatory teams in early access.


Share your details for early access, a conversation about how this fits your submission workflow, or a voice in how it gets built. A few quick questions, then, if it makes sense for both sides, a 20-minute conversation. No pitch.