TheraLyze AI
TheraLyze AI provides an AI-powered pharmacovigilance platform that automates Individual Case Safety Report case intake, MedDRA and WHODrug coding, and E2B(R3) regulatory submission for pharmaceutical companies and CROs.
- Company typePrivate
- Founded2024
- HeadquartersPleasanton, United States
- Headcount1–10
- GTM typeB2B
- OfferingSoftware
What TheraLyze AI does
TheraLyze AI (TheraLyze Inc.) is a Pleasanton, California-based, privately held company founded in 2024 by Sunil Kulkarni, a former engineering leader at Veeva Systems, that builds an AI-powered platform for pharmacovigilance case intake and Individual Case Safety Report (ICSR) management. The product automates the conversion of unstructured source documents — emails, Salesforce cases, call-center audio, web forms, SharePoint files, literature, E2B gateways, and EDC outputs — into E2B(R3)-compliant XML that can be submitted directly to major safety databases (Veeva Vault, ArisGlobal, Argus). The AI stack performs document extraction, MedDRA and WHODrug coding, seriousness and causality assessment, narrative generation, duplicate and follow-up detection, and 100+ language translation, with an explainable AI (xAI) layer that exposes the evidence behind each extraction and a configurable human-in-the-loop review step.
The portfolio spans three products: the ICSR Safety Suite (end-to-end ICSR management), the Safety Case Intake API (standalone intake processing), and the MedDRA API (standalone coding). Revenue is generated via tiered SaaS subscriptions — an Essentials tier for small pharma/biotech (single sponsor, up to 5 users) and an Enterprise tier for CROs and mid/large pharma (unlimited sponsors and users, multi-year contracts) — plus standalone API subscriptions. Pricing is custom and not publicly disclosed. Go-to-market is hybrid: a free 10-credit sandbox for self-serve evaluation layered with direct enterprise sales; distribution channels include the company's website, the Salesforce AgentExchange marketplace, and a GTM partnership with Winicker Norimed GmbH in Europe. Data is hosted exclusively in EU data centers (Ireland, Frankfurt), and the company holds SOC 2 Type II, ISO 27001:2022, HIPAA, GDPR, 21 CFR Part 11, EU GVP, EU AI Act, and GxP/GAMP 5 compliance certifications, with the documented milestone of producing the first AI-generated ICSR submitted to the EMA.
TheraLyze AI firmographics
Firmographics- Name
- TheraLyze AI
- Legal name
- TheraLyze Inc.
- Website
- https://theralyze.ai
- Company type
- Private
- Founded year
- 2024
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- TheraLyze AI provides an AI-powered pharmacovigilance platform that automates Individual Case Safety Report case intake, MedDRA and WHODrug coding, and E2B(R3) regulatory submission for pharmaceutical companies and CROs.
- Ownership category
- akta.pro rank
TheraLyze AI industry classification
Industry- Product category
- Pharmacovigilance Software
- NAICS
- Custom Computer Programming Services (541511)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Pharmacovigilance & Drug Safety Software (HLAGAJAK)
- akta.pro secondary industries
- Audit, Explainability & Accountability Tooling (traceability, reporting) (HDAAAKAL), Regulatory Readiness & Audit Automation (e.g., EU AI Act, NIST AI RMF, ISO/IEC 42001) (HDAAAMAE), Ethical Data Sourcing, Consent & Data Provenance (HDAAAMAI)
Keywords
Where TheraLyze AI is headquartered
LocationHeadquarters
- HQ city
- Pleasanton
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
TheraLyze AI business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Infrastructure, Marketing or Sales, Operations
Revenue model
- ICSR Safety Suite Subscription: SaaS subscription model for the full ICSR management platform with tiered pricing. Essentials tier for small pharma/biotech single-sponsor teams; Enterprise tier for CROs and large pharma with unlimited scale.
- Safety Case Intake API: Standalone API access for intake processing, allowing customers to integrate AI-powered case intake into existing pharmacovigilance systems without full ICSR Suite deployment.
- MedDRA API: AI-powered MedDRA coding API for medical terminology classification, available as standalone product.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Essentials for Small Pharma/Biotech |
| Subscription | Multi-year contract | Enterprise for CROs/Mid-Large Pharma |
| Subscription | Annual | Standalone API Products |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels6 records
TheraLyze AI product offering
Product offeringCore offering
TheraLyze AI provides an AI-powered pharmacovigilance platform that automates Individual Case Safety Report (ICSR) intake, data extraction, MedDRA/WHODrug coding, and generation of E2B(R3) compliant XML for regulatory submission. It processes source documents from email, Salesforce, call centers, web forms, SharePoint, literature, and E2B gateways, with optional human-in-the-loop validation, and delivers output directly to safety databases such as Veeva Vault, ArisGlobal, and Argus.
Product overview
TheraLyze AI offers a portfolio of AI-powered pharmacovigilance solutions organized around three core products: the ICSR Safety Suite (a complete platform for end-to-end Individual Case Safety Report management), the Safety Case Intake API (a standalone API for integrating AI-powered case extraction into existing workflows), and the MedDRA API (an AI-powered coding solution with explainable reasoning). The products support two deployment tiers: Essentials for small pharma/biotech teams (single sponsor, up to 5 users) and Enterprise for CROs and large pharma (unlimited sponsors/users, advanced features including WHODrug coding, 100+ language support, and voice transcription). All products share the same AI core for document processing and data extraction, with configurable human-in-the-loop validation and output in E2B(R3) XML format compatible with major safety databases.
Differentiator
Problem solved
Functional benefit
Products and services
- ICSR Safety Suite Complete Individual Case Safety Report (ICSR) management platform with AI-powered case intake, processing, medical review, and regulatory submission. Supports omni-channel intake from email, Salesforce, call centers, web forms, SharePoint, literature, and E2B gateways, with E2B(R3) XML output to safety databases. Targeted at pharma companies and CROs.
- Safety Case Intake API Standalone API for AI-powered pharmacovigilance case intake. Processes source documents and returns structured E2B(R3) XML data that can be integrated with existing safety databases. Enables organizations to integrate AI-powered extraction into their own workflows without deploying the full ICSR Suite.
- MedDRA API AI-powered MedDRA coding API that transforms patient language and medical documentation into accurate MedDRA codes. Features explainable AI reasoning showing the evidence and logic behind each code assignment, with traceability for regulatory compliance. Available as standalone API or integrated with ICSR Safety Suite.
Quantifiable outcome
- 95% reduction in case processing time (from ~4 hours per case to ~15 minutes per case)
- +3 more outcomes
Companies that use TheraLyze AI
Customer profileNamed customers2 records
Segments2 records
Ideal customer profiles2 records
TheraLyze AI technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration9 records
AI capability7 records
Feature7 records
TheraLyze AI partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- SalesforcecoreTheraLyze is listed on Salesforce AgentExchange as an approved application. The integration enables pharmacovigilance case intake directly within Salesforce environments, allowing organizations to process adverse event data through Salesforce interfaces.
- Winicker Norimed GmbHcorePartnership where Winicker Norimed offers TheraLyze's AI-powered case intake to their pharmaceutical clients. Winicker represents this as 'controlled integration of AI into their processes' and a way to offer clients reduced manual data entry with increased efficiency.
Scale indicators6 records
Recent moves5 records
Expansion highlights7 records
TheraLyze AI competitors and assessment
Company assessmentMarket position
Strengths1 record
Weaknesses1 record
Competitive moat6 records
Key risks6 records
Key highlights6 records
Customer concentration
TheraLyze AI social profiles
Digital presenceTheraLyze AI compliance and trust
Trust signalCompliance8 records
TheraLyze AI financial estimates
Financial estimateRevenue estimate
Valuation estimate
TheraLyze AI leadership team
Management profileNumber of profiles
Profiles1 record
TheraLyze AI funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
TheraLyze AI M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about TheraLyze AI
What does TheraLyze AI do?
TheraLyze AI provides an AI-powered pharmacovigilance platform that automates Individual Case Safety Report (ICSR) intake, data extraction, MedDRA/WHODrug coding, and generation of E2B(R3) compliant XML for regulatory submission. It processes source documents from email, Salesforce, call centers, web forms, SharePoint, literature, and E2B gateways, with optional human-in-the-loop validation, and delivers output directly to safety databases such as Veeva Vault, ArisGlobal, and Argus.
Is TheraLyze AI a public or private company?
TheraLyze AI is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was TheraLyze AI founded?
TheraLyze AI was founded in 2024. It employs 1 to 10 people.
Where is TheraLyze AI based?
TheraLyze AI is headquartered in Pleasanton, United States, in the North America region.
How does TheraLyze AI make money?
Three revenue lines are on record. ICSR Safety Suite Subscription is the primary driver. The others are safety Case Intake API and medDRA API.
Does TheraLyze AI have an API?
Yes. TheraLyze offers a Safety Case Intake API and MedDRA API as standalone products. The Safety Case Intake API processes source documents and generates E2B(R3) XML output that can be sent directly to safety databases. The MedDRA API provides AI-powered MedDRA coding with explainable AI reasoning. Both APIs are available via the ICSR Safety Suite platform with SSO authentication. The company offers a free sandbox with 10 case processing credits for evaluation.
What industry is TheraLyze AI in?
TheraLyze AI's product category is Pharmacovigilance Software. Its primary akta.pro industry code is HLAGAJAK, Pharmacovigilance & Drug Safety Software, with a secondary code of HDAAAKAL, Audit, Explainability & Accountability Tooling (traceability, reporting). Its NAICS code is 541511 and its SIC code is 7372.