Book Your Free Pharma AI Workshop
AI FOR PHARMA AUDIT

Find Every Compliance Gap Before Your Auditor Does

We build AI systems that digitize, search, and flag anomalies across pharmaceutical R&D, quality, and regulatory data — deployed on your infrastructure, never in the cloud.

See CDMO Case Study →
10+
Years of R&D data made searchable
5
Paying pharma clients, India & USA
CDMO
Proven at a leading Indian CDMO
On-Prem
Your IP never leaves your infrastructure

Search, Detect, and Report — Built for Pharma Audits.

Purpose-built for the compliance and regulatory audit challenges pharma companies are actively paying to solve — five paying pharma clients, on-premise by default.

[01]

Document & Compliance Search

Make every compliance document, SOP, batch record, and regulatory filing instantly queryable, so your teams stop spending hours searching and start finding answers in seconds.

  • Semantic search across all compliance and manufacturing documents
  • Natural language queries over SOPs, batch records, deviation reports, and regulatory filings
  • Deployed on-premise. Your documents never leave your infrastructure
  • Works across formats: PDFs, scanned docs, and structured reports
Find Anything Instantly Audit-Ready On-Prem
CDMOs Generics API Manufacturers
[02]

AI Agents for eTMF

Deploy AI agents across your electronic Trial Master File to surface the most relevant findings for QC audits, without your team manually reviewing hundreds of documents.

  • Agents dispatched across eTMF documents to identify and surface audit-relevant findings
  • Structured output organized by document type, risk level, and regulatory relevance
  • Dramatically reduces manual QC review time before inspections
  • Full audit trail of agent findings linked back to source documents
Faster QC Reviews Inspection-Ready Source-Linked
Regulatory Affairs CROs Clinical Operations
[03]

Automated APQR Generation

Automatically compile Schedule M-compliant Annual Product Quality Reviews by pulling batch records, deviations, stability data, and complaints directly from source systems — turning a weeks-long manual compilation into a same-day report.

  • Automatically aggregates batch review data, deviations, OOS/OOT results, stability studies, and complaint records for every commercialized product
  • Generates Schedule M-compliant APQR documents formatted to the client's internal review structure
  • Flags trends and anomalies across the review period for QA sign-off before submission
  • Deployed on-premise — source manufacturing and quality data never leaves client infrastructure
Schedule M Compliant Audit-Ready On-Prem
CDMOs QA / QC GMP Manufacturing

From Siloed R&D Data to an Institutional Knowledge Engine

How a leading Indian CDMO gave its formulation scientists the ability to search a decade of proprietary R&D data in seconds

CLIENT Leading CDMO, India

The Problem

The client, a leading contract development and manufacturing organization, had accumulated over a decade of proprietary R&D data: formulation studies, stability reports, excipient compatibility data, clinical batch records, and regulatory submissions. This knowledge lived across shared drives, spreadsheets, and disconnected document management systems.

When formulation scientists began new drug development projects, they had no reliable way to query what the organization already knew. Teams were unknowingly duplicating studies, starting formulations from scratch when relevant historical data existed, and losing weeks to knowledge retrieval that should have taken minutes.

The Solution

  • Deployed an on-premise AI-powered structured search system over the client's entire R&D document corpus. No data left their infrastructure
  • Built a semantic search layer that understands pharmaceutical terminology, enabling natural language queries like "show me stability studies for semi-solid formulations with carbomer base"
  • Connected structured outputs (formulation parameters, excipient grades, study outcomes) with unstructured narrative reports so scientists get complete context, not just document links
  • Implemented role-based access controls so proprietary client formulation data remained appropriately siloed while enabling cross-project knowledge sharing within permitted boundaries
  • Built automated Schedule M-compliant APQR generation, pulling batch, deviation, and stability data directly from source systems to turn a weeks-long manual compilation into a same-day report

The Impact

Seconds
Any compliance or manufacturing document surfaced on demand
10+ yrs
R&D Data Now Searchable
Zero
Data Left Infrastructure

"We had years of formulation and compliance data that was effectively invisible to our teams. Livo built something that made all of it searchable in a way our scientists actually use every day."

Founder, Leading CDMO

Pharma Audit & Compliance Leaders on Working with Livo

"We had years of formulation and compliance data that was effectively invisible to our teams. Livo built something that made all of it searchable in a way our scientists actually use every day."

Founder
Leading CDMO, India
Document & Compliance Search

"The eTMF review work that used to take our team days to prepare now gets surfaced in a fraction of the time. Livo's agents understand what matters in a regulatory context."

Sid Senroy
Founder, Regdev Inc.
AI Agents for eTMF

Three Steps. Zero Risk. Full IP Protection.

We start with two completely free steps. Every engagement is under NDA and deployable fully on-premise before you commit a rupee.

01

Free Pharma AI Workshop

A focused session with your R&D, regulatory, or quality team to identify the highest-value AI use cases in your organization. We bring pharma-specific frameworks. No sales pitch, just strategic clarity.

100% Free
02

Free AI Roadmap

We deliver a prioritized implementation roadmap with ROI estimates specific to your molecule pipeline, manufacturing scale, and regulatory markets. Yours to keep with no obligation.

100% Free
03

Pilot on Your Data

We build a working pilot on your actual data, deployed inside your infrastructure. You see results before you sign anything beyond the pilot scope. You're always in control.

Your Decision

Ready to See What's Inside Your R&D Data?

Book your free workshop. Bring your R&D head, your regulatory lead, or your QA director. We'll map exactly where AI creates the highest impact for your organization.

Built for the Compliance Reality of Drug Development

Pharma IP is your most valuable asset. Every system we deploy is designed to keep your data, your formulations, and your regulatory submissions inside your own walls.

🔒

On-Premise Deployment: IP Protection First

Your proprietary formulations, R&D data, and regulatory documents never touch a cloud environment. Full deployment inside your data center or private cloud. We bring the system to your data, not the other way around.

📋

21 CFR Part 11 Compatible

Systems designed with electronic records and electronic signatures requirements in mind. Full audit trails, access controls, and data integrity measures compatible with FDA electronic records standards for regulated environments.

GxP Data Integrity Principles

Built around ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate. Every data interaction is traceable. Designed to survive an FDA data integrity inspection without surprises.

🧪

ICH Q10 Pharmaceutical Quality System

AI systems structured around ICH Q10 quality management lifecycle, supporting continual improvement, CAPA management, and knowledge management across drug development and manufacturing.

🇮🇳

DPDP Rules India (2025) Compliant

Data processing and storage of Indian citizens on India servers. Full compliance with India's Digital Personal Data Protection Act, critical for Indian pharma companies handling patient or HCP data.

🌐

GDPR Compliant

Privacy and data protection by design for pharma companies with EU regulatory submissions, clinical trial data, or European manufacturing operations.

Pharma AI Expertise Without the Big Consulting Price Tag

Pharma AI is a specialized capability. Most AI vendors don't understand GxP. Most pharma consultants don't understand AI. We sit at the intersection.

Aspect
Big Consulting / SaaS AI Tools
Livo Assistant for Pharma
Pharma Domain Knowledge
Generic AI, pharma-specific add-ons
Built from day one for R&D & manufacturing
Data Sovereignty
Cloud-hosted, SaaS models
On-premise by default
Discovery / Workshop
₹40L–₹1.5Cr
Free
Pilot to Production
12–24 months
6–16 weeks
Team
Generalist management consultants
Senior AI engineers who've shipped pharma systems
Compliance Awareness
Bolt-on compliance layers
21 CFR 11, GxP, ICH Q10 from design

Start with zero risk. Get a pharma AI roadmap specific to your pipeline before committing a rupee.

Questions Pharma Leaders Ask Us

Everything you need to know before bringing AI into a regulated drug development environment.

Every system we build can be deployed fully on-premise inside your data center or private cloud. Your formulation data, stability studies, and batch records never leave your infrastructure. We work under NDA from first conversation. For CDMOs with multiple client formulations, we also implement role-based access controls to keep client data appropriately siloed.

We design systems compatible with 21 CFR Part 11 electronic records requirements, with full audit trails, access logs, and data integrity controls are built in. We follow GxP data integrity principles (ALCOA+) by design. We don't add compliance as an afterthought; it shapes how we architect data flows from the start. For validation activities, we can provide IQ/OQ/PQ documentation support.

We work with CDMOs, generics manufacturers, API producers, and specialty pharma companies. One of our engagements was with a leading CDMO, and the R&D knowledge search use case is directly applicable to any formulation-heavy organization sitting on years of proprietary study data. We also engage with branded pharma companies on regulatory intelligence and pharmacovigilance use cases.

Most pilots are live in 6–10 weeks. The longest part is typically data access and infrastructure setup on your side. The AI system itself builds fast once we have a clear data pipeline. Full production deployment with validation documentation typically takes 3–5 months. We won't over-promise timelines; pharma implementations have real compliance steps that take time to do properly.

Yes. We build connectors to existing document management systems (Veeva Vault, OpenText, SharePoint), LIMS platforms, SAP, and custom legacy systems. Our approach is to enhance your existing infrastructure, not replace it. The AI layer sits on top of your current systems, making their data usable without disrupting validated workflows.

A focused 2–3 hour session (remote or on-site) with your relevant functional leaders: R&D, regulatory, QA, or medical affairs depending on your priorities. We map your current data assets and workflows, identify the top 3–5 AI use cases by ROI potential, and discuss feasibility given your compliance constraints. You leave with a concrete view of where AI creates the most value for your specific organization.

We bring McKinsey-grade strategy with senior AI engineering execution

Soumya Sharma - Co-Founder

Soumya Sharma

Co-Founder

Ex-McKinsey
IIM-Ahmedabad
IIT-Delhi, Computer Science

Kangana Pandiya - Co-Founder

Kangana Pandiya

Co-Founder

Ex-McKinsey
IIM-Ahmedabad

Let's Map Your Pharma AI Opportunity

Book a 30-minute discovery call with our team. We'll identify your highest-ROI use case, whether it's R&D search, regulatory intelligence, quality analytics, or pharmacovigilance, and map out a compliant implementation path.