Life Sciences

Compliant Technology for Pharma and Contract Manufacturing

India produces 20% of the world's generic medicines and is home to over 4,200 biotech startups — with a domestic pharma market on track for $130 billion by 2030. CDSCO compliance, FDA 21 CFR Part 11 requirements, and the operational complexity of contract manufacturing create technology problems that generic cloud platforms don't solve out of the box.

ITMTB builds compliant, production-grade platforms for pharma, biotech, and contract manufacturing — from formulation management and supply chain systems to R&D data pipelines and regulatory automation.

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Selected work in life sciences

an anonymized pharma compliance AI implementation

Pharma Compliance AI: How We Designed a Platform for SOP, BMR and FDA Warning Letter Review

Limited-scale platform execution with scalable design, traceable findings, human review, Azure AD login, and AWS deployment

Global Contract Formulation Manufacturer serving FMCG and Pharma sectors

Transforming Chemical Formulations: A Case Study of Innovation in Contract Manufacturing

92% reduction in raw material selection errors — 12% faster turn-around-time in 2 months post go-live

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For a regulated pharma example, see our implementation story on AI-assisted SOP, BMR, and warning-letter review with source evidence, reviewer control, and auditability designed into the workflow.

Clients we've worked with

Landscape and Opportunities

$130 billion Projected size of India's domestic pharmaceutical market by 2030 — growth that demands scalable technology infrastructure.
20% India's share of the global generic medicines supply — manufactured at scale, requiring production systems that are both efficient and audit-ready.
18% YoY export growth — pharma and biotech firms scaling exports face increasing pressure to meet global regulatory standards, not just domestic ones.
4,200 Biotech startups expected to emerge in India — creating demand for R&D platforms that can move at startup speed while meeting enterprise compliance requirements.

Technology as a Catalyst for Change

Formulation and Contract Manufacturing Platforms

AI-Assisted R&D and Drug Discovery

Regulatory Compliance Automation

Clinical and Research Data Management

Integration: Where Life Sciences Technology Stalls

Disconnected systems are the most common source of delay and cost in pharma operations.

Most life sciences technology failures are integration failures: ERP systems that cannot talk to manufacturing execution systems, LIMS that cannot feed data to regulatory submission tools, clinical data platforms that require manual export before analysis. We architect the integration layer as a first-class deliverable — not an afterthought — connecting the systems your teams use into workflows that run without manual intervention.

Why ITMTB for Life Sciences?

We built a cloud-based formulation and supply chain platform for a global contract manufacturer serving major consumer health and FMCG firms — delivering a 92% reduction in raw material selection errors and a 12% improvement in turnaround time within two months of go-live. Deployments are designed for CDSCO and FDA 21 CFR Part 11 compliance, with audit trail, electronic-signature, and validated cloud requirements built in from the outset.

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How an engagement works

No open-ended retainers. Every engagement starts with a bounded, fixed-price discovery.

Discovery sprint

2 weeks, fixed price. We scope the problem, audit your data, and produce a written roadmap, cost estimate, and risk register. You decide whether to proceed — no commitment beyond the sprint.

Build

Fixed-scope first phase or time-and-materials with a cap. Production-grade code, not a prototype. Delivered into your cloud environment with tests, monitoring, and handoff documentation.

Operate

4–8 week warranty period post-handoff. Bugs and regressions fixed at zero cost. Ongoing ops available — we don't disappear after delivery.

Full methodology and engagement shapes →