Pharmaceuticals & Life Sciences
Custom Software Development for Pharmaceuticals & Life Sciences
Custom Software Development for pharmaceuticals & life sciences, built around the constraint that defines the sector: GxP validation means every system change needs documented evidence before it reaches production.
- Regulations in scope
- 5
- Systems we integrate
- 5
- Typical first release
- 6 weeks
What changes when it is pharmaceuticals & life sciences
You own everything: source, infrastructure definitions, documentation. Custom software that only your vendor can run is not an asset, it is a subscription with extra steps.
In pharmaceuticals & life sciences, GxP validation means every system change needs documented evidence before it reaches production. That single fact reshapes how custom software development has to be built here, the guardrails, the approval points and the evidence trail are design inputs rather than things bolted on before go-live.
The workload we are most often asked to take on first is literature monitoring, usually integrated against SAP. We build the smallest thing that proves the case, put it in front of real users, and expand only what earns its keep.
Multi-model by default, so a provider outage is a routing decision rather than an incident. You own the code, the models where they are open-weight, and the documentation to run it without us.
The sector constraints we design around
- Defining constraint
- GxP validation means every system change needs documented evidence before it reaches production
- Regulations in scope
- CDSCO · US FDA 21 CFR Part 11 · EU GMP Annex 11 · GxP validation · ICH guidelines
- Systems of record
- LIMS · QMS · eTMF · SAP · pharmacovigilance databases
- Where we usually start
- batch record review
Custom Software Development workloads in pharmaceuticals & life sciences
- batch record review
- adverse event intake and coding
- regulatory dossier assembly
- deviation and CAPA drafting
- literature monitoring
What is included
- Process mapping before any build, what people actually do, not the documented version
- Architecture sized to your real users and data volume
- Role-based access and audit logging from the start
- Integration with the systems you already run
- Automated tests and a deployment pipeline
- Full source, documentation and IP transfer
Questions from this sector
Can an AI system be GxP validated?
Yes, with a documented validation approach, IQ/OQ/PQ, defined intended use, change control and evidence of consistent performance. We build the validation pack alongside the system, not afterwards.
How do you handle 21 CFR Part 11?
Audit trails, electronic signatures, access control and record integrity designed in from the start, because retrofitting them is effectively a rebuild.
Custom or off-the-shelf?
Off-the-shelf whenever it fits. It is cheaper to buy and someone else maintains it. Custom earns its cost when your process is genuinely a differentiator, or when configuring a product would cost more than building the thing.
How much does custom software cost?
Driven by user roles, integration count and data complexity rather than by feature list length. We scope against a process map, which is why our estimates hold better than a number given on a first call.
Who owns the software?
You do, source, IP and infrastructure, transferred on completion. It runs in your accounts and keeps running without us.
Custom Software Development in other sectors
Other capabilities for pharmaceuticals & life sciences
- AI Agent Development for Pharmaceuticals & Life Sciences
- Agentic Workflow Automation for Pharmaceuticals & Life Sciences
- LLM Application Development for Pharmaceuticals & Life Sciences
- RAG & Knowledge Retrieval for Pharmaceuticals & Life Sciences
- Chatbot Development for Pharmaceuticals & Life Sciences
- Document Processing & IDP for Pharmaceuticals & Life Sciences
- AI Copilot Development for Pharmaceuticals & Life Sciences
- Data Engineering for Pharmaceuticals & Life Sciences
- Enterprise AI Platform for Pharmaceuticals & Life Sciences
- Workflow & Integration Automation for Pharmaceuticals & Life Sciences
Custom Software Development for pharmaceuticals & life sciences, worth a conversation?
Tell us the workload and the regulation it sits under. We will tell you what is realistic.
Or email bd@dtrasglobal.com · call +91 74118 77878
