We build AI systems that make pharmaceutical R&D, quality, and regulatory data searchable and usable — deployed on your infrastructure, never in the cloud.
Purpose-built for the data challenges that slow down formulation scientists, regulatory teams, and quality operations.
Make 10+ years of formulation studies, stability data, and lab notebooks instantly queryable — so scientists stop reinventing what your organization already knows.
Convert unstructured regulatory documents — CTD modules, NDA/ANDA submissions, stability reports — into structured, searchable data that accelerates submissions and gap analysis.
Detect Out-of-Specification patterns, surface CAPA trends, and connect batch deviations to root causes — before they escalate into observations or warning letters.
Aggregate and analyze adverse event reports, HCP communications, and literature signals to surface safety concerns before they become regulatory obligations.
How a leading Indian CDMO gave its formulation scientists the ability to search a decade of proprietary R&D data in seconds
Encube Ethicals, 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, lab notebooks, 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.
"Our scientists can now query what we already know before starting any new formulation project. It has fundamentally changed how we reuse institutional knowledge."
Every pharma R&D organization is sitting on a goldmine of proprietary data that no one can effectively search. The challenge isn't generating data — it's making existing knowledge findable at the moment scientists need it most.
We start with two completely free steps. Every engagement is under NDA and deployable fully on-premise before you commit a rupee.
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% FreeWe 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% FreeWe 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 DecisionBook 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.
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.
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.
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.
Built around ALCOA+ principles — Attributable, Legible, Contemporaneous, Original, Accurate. Every data interaction is traceable. Designed to survive an FDA data integrity inspection without surprises.
AI systems structured around ICH Q10 quality management lifecycle — supporting continual improvement, CAPA management, and knowledge management across drug development and manufacturing.
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.
Privacy and data protection by design for pharma companies with EU regulatory submissions, clinical trial data, or European manufacturing operations.
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.
Start with zero risk. Get a pharma AI roadmap specific to your pipeline before committing a rupee.
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 — 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. Our Encube Ethicals engagement was with a 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.
Co-Founder
Ex-McKinsey
IIM-Ahmedabad
IIT-Delhi, Computer Science
Co-Founder
Ex-McKinsey
IIM-Ahmedabad
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.
Discover 3 high-ROI pharma AI use cases tailored to your organization — R&D search, regulatory intelligence, or quality analytics. No cost. No commitment. Just clarity.
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