Pharmaceuticals & Life Sciences
API Design & Integration for Pharmaceuticals & Life Sciences
API Design & Integration 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
Idempotency keys on every write endpoint prevent the duplicate-charge class of bug entirely. It is a small amount of work that removes an entire category of incident.
In pharmaceuticals & life sciences, GxP validation means every system change needs documented evidence before it reaches production. That single fact reshapes how api design & integration 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 regulatory dossier assembly, usually integrated against SAP. Every engagement opens with a measurement: the cycle time, the cost per transaction, or the error rate we are being asked to move.
Deployed across regulated and unregulated sectors, with audit trails where the regulator expects them. 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
API Design & Integration 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
- OpenAPI specification written before the implementation
- Versioning strategy that does not break consumers
- Authentication, scopes and rate limiting
- Webhooks with retries and signature verification
- Idempotency on every state-changing endpoint
- Generated documentation and a sandbox
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.
REST or GraphQL?
REST for partner-facing and public APIs where caching and simplicity matter; GraphQL where a first-party client needs flexible, varied queries. Most systems end up with both, used deliberately.
Do you document it?
Generated from the OpenAPI specification, with a working sandbox. Documentation written by hand and separately always drifts.
Can you integrate with legacy SOAP systems?
Yes, usually by wrapping them in a clean modern interface rather than exposing the legacy contract onward.
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
API Design & Integration 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
