# Livo Assistant for Pharma: AI for Compliance Search & Audit-Ready eTMF Source: https://livoassistant.com/pharma Livo Assistant builds AI systems for pharmaceutical companies and CDMOs: compliance document search, AI agents that surface audit-relevant findings across eTMF, and automated Schedule M-compliant APQR generation. Proven at leading CDMOs. --- Livo Assistant for Pharma: AI for Compliance Search & Audit-Ready eTMF 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. [Talk to a founder → ](https://livoassistant.com/pharma#contact) Free guide The Pharma Inspection Readiness Guide — 9-page PDF for QA & regulatory teams. [Read the guide → ](https://livoassistant.com/guides/pharma-inspection-readiness) 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 PHARMA AUDIT AI ## 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 CASE STUDY ## 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 knowledg e 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 WHAT CLIENTS SAY ## 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 HOW WE ENGAGE ## 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? Start with the readiness guide, or book 30 minutes with a founder to map where AI adds the most coverage on your work. PHARMA COMPLIANCE & DATA SECURITY ## 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. WHY Livo Assistant ## 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. PHARMA FAQ ## 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 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. FREE GUIDE ## The Pharma Inspection Readiness Guide The six systems inspectors examine, data-integrity expectations, the document set to assemble, and how to run the inspection so it holds up. For QA and regulatory teams. [Get the guide → ](https://livoassistant.com/get-the-guide?guide=pharma) LEADERSHIP ## We bring McKinsey-grade strategy with senior AI engineering execution ### Soumya Sharma Co-Founder Ex-McKinsey IIM-Ahmedabad IIT-Delhi, Computer Science [Connect on LinkedIn ↗ ](https://www.linkedin.com/in/rithn/) ### Kangana Pandiya Co-Founder Ex-McKinsey IIM-Ahmedabad [Connect on LinkedIn ↗ ](https://www.linkedin.com/in/kangana-pandiya/) ## 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. Thank you! We'll reach out within 24 hours to schedule your discovery call. Or [email us directly ](mailto:soumya@livoassistant.com)