Digital platforms for pharmaceutical manufacturers, CROs, clinical trials, regulatory + pharmacovigilance, and R&D — end-to-end life-sciences technology.
We serve pharmaceutical manufacturers, biotech companies, contract research organisations (CROs), clinical trial sponsors, medical-device makers, and diagnostics companies. Our platforms cover the full life-sciences value chain — from R&D + preclinical + clinical trial management to regulatory dossier assembly, pharmacovigilance, manufacturing (MES + batch record), quality (QMS), and commercial + distribution.
Signature capabilities include electronic Trial Master File (eTMF), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), pharmacovigilance case management (E2B R3), regulatory dossier assembly (eCTD), GMP-compliant batch records, LIMS integration, and cold-chain distribution tracking. Compliant with US FDA (CFR 21 Part 11), EMA, CDSCO, WHO-GMP, and ICH guidelines.
Concrete capabilities you get when you engage Ketpy for Pharmaceuticals & Life Sciences Solutions.
The kinds of businesses and use-cases Pharmaceuticals & Life Sciences Solutions is engineered to serve.
MES + eBR + QMS + LIMS integration + serialisation for WHO-GMP + FDA-approved facilities.
CTMS + EDC + eTMF + patient engagement + regulatory dossier assembly.
Cell + gene therapy tracking, chain-of-custody, and personalised-medicine workflows.
UDI compliance, medical-device vigilance, and post-market surveillance dashboards.
Measurable business benefits our customers report after adopting Pharmaceuticals & Life Sciences Solutions.
What you get when you partner with us on Pharmaceuticals & Life Sciences Solutions.
Certified senior engineers with 10+ years building Industry systems for regulated and high-growth businesses.
From discovery and design through implementation, deployment, and steady-state operations — one accountable team.
Two-week sprints with working demos, transparent burn-downs, and outcomes you can measure each fortnight.
Distributed senior teams in India, UK, US, and UAE — your delivery window matches your business hours.
ISO 27001 certified processes, SOC 2 ready, GDPR and HIPAA-aware controls baked in from day one.
Fixed-bid, time-and-material, dedicated squad, or staff augmentation — we match the model to your reality.
We map your business goals, current state, constraints, and the success metrics that matter to you. Output: a written brief with prioritised use-cases.
We define the right approach, target architecture, and a phased delivery plan with clear milestones, dependencies, and risk register.
Our architects design solutions that are scalable, secure, observable, and maintainable. We share the design with your engineers for review.
We build in bi-weekly sprints with working demos, automated testing, and code reviews. You see progress every two weeks, not at the end.
We roll out with zero-downtime strategies — blue-green, canary, feature flags — and a documented rollback plan for every release.
We hand over with full documentation and runbooks, then stay engaged for support, optimisation, and continuous improvement.
Tools and platforms we use day-to-day for Pharmaceuticals & Life Sciences Solutions. We are tool-agnostic — we pick what fits your stack.
Fully. Electronic records + electronic signatures with system + procedural controls. Audit trails are tamper-evident. Validation lifecycle documentation (IQ/OQ/PQ) provided with every deployment. FDA-ready for inspection.
Yes. Indian serialisation (2D DataMatrix + track-and-trace per CDSCO), US DSCSA (T3), EU FMD (2D + tamper seal), and China NMPA. Aggregation + traceability across supply chain to pharmacy shelf.
Yes. Native SAP S/4HANA + Oracle EBS + ERPNext connectors for batch → SAP inventory + cost accounting. Master data governance with 2-way sync for materials + BOMs.
Yes. CDSCO ADR reporting, WHO-GMP audit-ready batch records + deviations + CAPA, and Schedule M compliance built in. Regulatory affairs teams generate submissions in hours, not weeks.
Tell us what you are building and we will get back inside one business day with a written brief and a recommended next step.
Trusted By Industry Leaders & Rated 5-Star
