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AI-Powered Life Sciences Platform

AI Operating System
for Life Sciences

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200+ years of industry expertise empowering us

Backed by two centuries of proven expertise, we bring unmatched knowledge and reliability to every solution.

Backed by the best in the industry

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Dr. Jayanth Sridhar
Investor and Advisor

Dr. Jayanth Sridhar

CEO, Biologics, Dr. Reddy's

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Dr. Mahesh Bhalgat
Advisor

Dr. Mahesh Bhalgat

CEO, Veeda LifeSciences

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Rajneesh Raina
Advisor

Rajneesh Raina

VP, IT Eikon Therpeutics

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Venkat Bundla
Investor and Advisor

Venkat Bundla

CEO, Garphi Biosciences

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Ganapathy Muthukumar
Advisor

Ganapathy Muthukumar

VP, AHA Bioconsultants

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Dr. Arun Upadhyay
Advisor

Dr. Arun Upadhyay

CSO, Ocugen

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AragenClonz BioTechPopvaxInva Pharma

One platform for Global Compliance

Zenopsys ISO 13485 complianceZenopsys FDA complianceZenopsys MHRA complianceZenopsys GMP complianceZenopsys TGA complianceZenopsys ISO 22716 complianceZenopsys ISO 9001:2015 complianceZenopsys ISO 14971 complianceZenopsys FDA 21 CFR Part 11 complianceZenopsys CGMP complianceZenopsys ICH complianceZenopsys ISO 13485 complianceZenopsys FDA complianceZenopsys MHRA complianceZenopsys GMP complianceZenopsys TGA complianceZenopsys ISO 22716 complianceZenopsys ISO 9001:2015 complianceZenopsys ISO 14971 complianceZenopsys FDA 21 CFR Part 11 complianceZenopsys CGMP complianceZenopsys ICH compliance
One AI Platform for Life Sciences

One AI Powered Platform
From RnD to Commercial Operations

Streamline your entire product journey on one intelligent platform. We unify all your critical data—from batch records and SOPs to complaints and regulatory submissions—using the power of AI. This single source of truth fosters improved collaboration, automates routine tasks, proactively identifies risks, and ensures seamless GxP compliance. By connecting R&D with commercial operations, we empower your teams to reduce costs, improve quality, and accelerate your time to market.

Streamline your entire product journey on one intelligent platform. We unify all your critical data—from batch records and SOPs to complaints and regulatory submissions—using the power of AI. This single source of truth fosters improved collaboration, automates routine tasks, proactively identifies risks, and ensures seamless GxP compliance. By connecting R&D with commercial operations, we empower your teams to reduce costs, improve quality, and accelerate your time to market.

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AI-Powered Tools

AI-Powered Tools for Each Phase of the Product Lifecycle

Our platform powers every phase of the life sciences lifecycle with a suite of specialized, AI-driven modules. This integrated toolkit includes our Manufacturing Execution System (MES), Quality Management System (QMS), Document Management System (DMS), Learning Management System (LMS), and a unified ELN + LIMS. Each module is built with a relentless focus on the user, featuring an intuitive interface and a seamless experience that feels natural from day one.

Quality Management System

Close out deviations and CAPAs faster while simplifying your compliance needs. Our QMS provides a single source of truth for all your quality processes, from risk and audit management to change control and CAPAs, helping you maintain constant GxP compliance with less effort.

Document Management System

Learning Management System

Manufacturing Execution System

Electronic Lab Notebook

Quality Management System interface
Document Management System interface
Learning Management System interface
Manufacturing Execution System interface
Electronic Lab Notebook interface
Testimonials
Jayanth Sridhar avatar

When reviewing the platform, it's clear it was engineered with growth in mind. The unified solution is inherently more scalable than trying to bolt on different systems during a high-growth phase.

Jayanth Sridhar

CEOBiologics, Dr. Reddy's

They've clearly spent time thinking about the end-user on the production floor. The interface is intuitive, providing clear instructions and context at each step of batch execution.

Muralidhar

COOClonzbio

The most compelling argument for Zenopsys from an IT standpoint is its unified platform approach. They’ve built a single, coherent GxP operating system rather than an assembly of acquired parts.

Radhakrishnan

VP ITBiocon

With simplified processes, instant, audit-ready records and transparent reporting, a CMO using Zenopsys can use their state of compliance as a proactive sales tool.

VP of OperationsCMO, CA, USA

Varun Chandra avatar

For brands that outsource manufacturing, this ability to extend GxP control and maintain a single source of truth with their CMOs is a significant leap forward in mitigating risk.

Varun Chandra

Vice President of R&D, Quality, and RegulatorySeneGence

Industries We Support

Tailored Solutions for Every Life Sciences Sector

Our modular platform seamlessly adapts to the unique workflows of each sector — accelerating innovation, ensuring compliance, and driving operational excellence.

Bio Pharma Manufacturing

Bio Pharma Manufacturing

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Medical Devices

Medical Devices

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Contract Research

Contract Research

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Cosmetics

Cosmetics

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Nutrition Supplements

Nutrition Supplements

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Food Production

Food Production

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Platform Capabilities

Engineered for Simplicity, Automation and Regulatory Compliance

Intelligence indicatorIntelligence

AI-First Automation

Go beyond simple automation with a suite of AI co-pilots integrated into your workflows. Effortlessly author documents, get instant answers, accelerate root cause analysis with Investigation Agents, and auto-generate training assessments.

Document authoring iconDocument Authoring
Investigation agent iconDocument Q&A
Training assessment iconInvestigation and CAPA Agents
Training assessment iconTraining Assessment Generation

Document Authoring

Document Authoring

No Code Process Builder

No code process builder
Intelligence indicatorAgile

Collaboration and Configuration

Adapt the platform to your unique operational needs without lengthy implementation. Use the no-code process builder to digitise your workflows, foster seamless teamwork with in-built conversations on any record, and design flexible review and approval cycles that match how your teams actually work.

Document authoring iconNo Code Process Builder
Investigation agent iconInbuilt Conversations
Training assessment iconConfigurable Reviews and Approvals
Intelligence indicatorComprehensive

Full Spectrum Compliance & Security

Operate with confidence on a platform built for GxP compliance software and enterprise-grade security. Every action is recorded in a comprehensive, immutable audit trail, and granular Role-Based Access Control ensures the right people have the right access, by design.

Document authoring iconComprehensive Audit Trails
Investigation agent iconEnterprise-Grade Security
Training assessment iconRole-Based Access Controls

Role Based Access Control

Role based access control
Benefits

Accelerate Timelines Without Compromising Compliance

Our platform eliminates the traditional trade-off between speed and regulatory diligence. By automating critical GxP workflows and unifying your data, we make the compliant path the fastest path. This allows you to drastically shorten development and release cycles with the confidence that every action is documented and your organisation is always audit-ready.

Face Audits with Confidence

Face Audits with Confidence

Centralize your quality processes, documents, and training records with our platform for a single, searchable source of truth. Confidently demonstrate control and answer auditor requests instantly with a complete audit trail.

Proactively Prevent Deviations

Proactively Prevent Deviations

Shift from reactive firefighting to proactive quality control, saving time and money. Our system prevents human error by ensuring operators use only calibrated equipment and the latest SOPs. Digital process enforcement reduces deviations, minimizes rework, and lowers overall quality costs.

Minimize Administrative Work

Minimize Administrative Work

Stop allowing your highly skilled experts to spend their day on low-value administrative work. Our AI-powered platform automates the repetitive tasks that consume your team's time, from authoring documents (DMS) to analyzing quality events and tracking training (QMS & LMS).

Impacts

Driving Impact Across Every Milestone

100% Visibility

100% Visibility

Gain complete visibility into manufacturing and quality data with a unified dashboard. Instantly identify issues and make informed decisions to maintain smooth operations.

Easy Collaboration

Easy Collaboration

Unify manufacturing, quality, and compliance teams on one platform for a single source of truth, eliminating communication delays and speeding up approvals and issue resolution.

Reduce cycle times

Reduce Cycle Times

Streamline operations with automated workflows, reducing cycle times for quality processes and batch release, thus boosting throughput and agility.

30% Quicker Batch Release

30% Faster Batch Release Chart
Reduction in Quality Admin Time

> 90%

10 - 15%

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Reduced deviations

30%

Up to 3

Unify GxP Operations in One AI platform

Frequently Asked Questions

1. Is Zenopsys compliant with 21 CFR Part 11 and EU Annex 11?Expand

2. What validation documentation is available for Zenopsys?Expand

3. Can Zenopsys integrate with our existing technology stack?Expand

4. How quickly can our teams go live with Zenopsys?Expand

5. What's the pricing model of Zenopsys?Expand

About Us

Who We Are ?

We are driven by a passion to free brilliant scientists and operators from the regulatory complexities that hold them back. Backed by venture capital and a dream team of industry advisors, we are building the future of intelligent, effortless compliance, ensuring companies can bring life-changing products to market faster and more safely than ever before.

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Varun Jampala

Varun Jampala

Co-Founder, Zenopsys

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Sriharsha Challa

Sriharsha Challa

Co-Founder, Zenopsys