What Alchemi does

Alchemi is a New York-based, private AI software company founded in 2024 that builds AI agents purpose-built for regulated drug development. Its platform deploys scientific agents across the full development lifecycle, including non-clinical studies, clinical, bioanalysis, CMC, regulatory submissions, and safety, with three core modules: Regulatory Authoring (documentation drafting up to 90% faster), AI-Assisted Review (automated QC/QA flagging against guidelines, SOPs, and study criteria), and Shared Spaces (GxP-compliant collaborative document analysis). The company's technical differentiation centers on a proprietary Context Layer that connects agents to customer data and encodes business logic such as SOPs, combined with human-in-the-loop workflows that link every AI action to an auditable source for 21 CFR Part 11 compliance.

The platform is delivered as a single-tenant enterprise SaaS deployment with built-in compliance for SOC 2 Type II, ISO 27001, ISO 9001, GDPR, GxP, and 21 CFR Part 11, and integrates natively with LIMS, ELN, RIM, SharePoint, and the IDBS Polar platform via a 2026 partnership with IDBS (a Danaher company). Revenue is generated through subscription-based access following a 2-week onboarding process that includes advise/design, knowledge integration, and adaptive optimization phases; pricing is not publicly disclosed and is sold through a consultative, demo-led enterprise motion. Customers include top-10 pharma, top-3 CROs, top-5 global CROs, and Tier 1 CROs, with stated outcomes of 3,000+ studies supported annually and 70% faster regulatory document production. The company is venture-backed with a $3.3M seed round (Flybridge, Maple VC, Nebular) and operates with 11-50 employees out of New York.

Name

Alchemi

Legal name

Alchemi

Website

https://alchemi.bio

Company type

Private

Founded year

2024

Operating status

Operating

Headcount range

11–50 employees

Short description

Alchemi builds domain-specialized AI agents that automate regulatory documentation, QC/QA review, and collaborative analysis for pharmaceutical companies, biotechs, and CROs across the drug development lifecycle, sold as compliant enterprise SaaS.

Ownership category

akta.pro rank

Product category

AI Software for Drug Development

NAICS

Software Publishers (5132)

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

Regulatory Readiness & Audit Automation (e.g., EU AI Act, NIST AI RMF, ISO/IEC 42001) (HDAAAMAE)

akta.pro secondary industries

Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH), AI Integration & Orchestration Platforms (Connectors, Workflow, iPaaS for AI) (HDAEANAI), AI Governance, Risk & Compliance (GRC) Platforms (HDAAAMAA)

Keywords

• AI drug development
• Regulatory authoring
• Life sciences AI
• Clinical research automation
• GxP compliant software

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Marketing or Sales, Infrastructure, Operations

Revenue model

1. AI Platform/SaaS Subscription: Alchemi generates revenue through subscription-based access to their AI agent platform, which includes deployment of scientific agents across development workflows. The platform is tailored to specific customer operations through a 2-week onboarding process involving advise/design, knowledge integration, and adaptive optimization phases.

Distribution channels1 record

Marketing channels3 records

Core offering

Alchemi develops a purpose-built AI agent platform for regulated drug development, deploying scientific AI agents across non-clinical, clinical, bioanalysis, CMC, regulatory submissions, and safety workflows. The platform streamlines regulatory documentation by up to 90% and accelerates document production by 70% while maintaining 21 CFR Part 11, GxP, SOC 2 Type II, ISO 27001, and ISO 9001 compliance. It includes Regulatory Authoring, AI-Assisted Review, and Shared Spaces modules, with a proprietary Context Layer that grounds AI responses in customer data and SOPs.

Product overview

Alchemi is a purpose-built AI platform for regulated drug development that deploys scientific agents across all phases of the development lifecycle (Non-clinical, Clinical, Bioanalysis, CMC, Regulatory Submissions, and Safety). The platform consists of three core modules—Regulatory Authoring, AI-Assisted Review, and Shared Spaces—alongside specialized solution areas for Non-clinical workflows. The platform differentiates through a proprietary Context Layer that connects agents to customer data and encodes business logic, and a human-in-the-loop system that maintains audit trails and compliance. Customers report up to 90% streamlining in regulatory documentation and 70% faster document production while maintaining 21 CFR Part 11 compliance.

Differentiator

Problem solved

Functional benefit

Products and services

• Alchemi Platform A purpose-built AI platform for regulated drug development that deploys scientific agents across critical development workflows (Non-clinical, Clinical, Bioanalysis, CMC, Regulatory Submissions, Safety). Includes Regulatory Authoring, AI-Assisted Review, and Shared Spaces modules, with built-in compliance, full audit trails, and human-in-the-loop workflows for pharmaceutical companies, biotech firms, and CROs.
• Non-clinical Solutions AI-powered workflow solutions for non-clinical drug development, including AI-assisted data review, toxicology report drafting, and SEND data conversion to streamline the path to IND for pharmaceutical and biotech companies.

Quantifiable outcome

• Reduces regulatory document turnaround time by up to 90%
• +4 more outcomes

Named customers6 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

AI capability7 records

Feature5 records

Partnerships

One partnership is on record.

• IDBS (Danaher company)coreTechnology or Integration · 16 June 2026IDBS, a Danaher company, and Alchemi announced a partnership to connect AI agents to the IDBS Polar platform for biopharma regulatory filings. The integration allows CMC teams to draft regulatory submissions from governed data while maintaining 21 CFR Part 11 compliance. Alchemi routes all drafts through human-in-the-loop review workflows, ensuring the compliance chain remains intact from data source to regulatory submission.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• Benchling: Benchling is a biotech R&D cloud platform used by leading biotechs for ELN, molecular biology, and registry data, and is layering AI into R&D workflows. It targets similar biotech and large-pharma R&D customers, though it is less regulatory-submission focused than Alchemi.
• TetraScience: Tetrascience provides a scientific data cloud and AI-ready infrastructure for life sciences R&D, integrating with ELN, LIMS, and instrument systems. It is an adjacent AI/data infrastructure peer for the same regulated customer set.
• Recursion Pharmaceuticals: Recursion applies AI and high-throughput biology to drug discovery with its own pipeline. It is a comparable AI-for-pharma company in the broader theme, even though it is vertically integrated into drug development rather than a SaaS vendor.
• Insilico Medicine: Insilico Medicine is an AI-driven drug discovery and development company using generative AI across the pharma R&D lifecycle. It overlaps with Alchemi in applying AI to accelerate regulated drug development, though it is more discovery- than regulatory-focused.
• IDBS (Danaher): IDBS is the Polar platform partner that Alchemi is integrating with; IDBS provides biopharma process and CMC data management. The relationship is mutually productive, but IDBS could also become a competitor by building or acquiring similar agent capabilities.

Broad incumbents

• Veeva Systems: Veeva is the dominant SaaS provider for life sciences, with deep Regulatory Information Management (RIM) and Vault platform offerings spanning clinical, regulatory, and quality. It is the most direct broad incumbent competing for the same regulated R&D workflows Alchemi targets, with an established enterprise footprint.
• IQVIA: IQVIA is a global life sciences technology and services giant offering AI-driven clinical, regulatory, and R&D solutions. It is both a customer-adjacent advisor source for Alchemi and a broad competitor covering overlapping regulatory and analytics workflows.

Direct peers

• Certara: Certara provides regulatory science, modeling & simulation, and software used across drug development including regulatory submissions. It directly overlaps with Alchemi's regulatory authoring and review capabilities for biopharma.
• ArisGlobal: ArisGlobal offers LifeSphere, a regulatory, safety, and clinical platform for life sciences, with growing AI capabilities across document authoring and pharmacovigilance. It is a direct competitor in regulated R&D software for pharma and CROs.
• Dotmatics: Dotmatics provides an R&D scientific platform spanning ELN, LIMS, and data workflows, recently expanded with AI features. It directly competes for the same scientist and regulatory user base with comparable integration points.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/alchemibio

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds1 record

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Alchemi