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Ontogenesis Technologies

Case study — Pharma & Life Sciences

AI MedAssist: AI platform for pharmaceutical regulatory documentation

A vaccine manufacturing company needed an AI-powered documentation portal to automate regulatory guidelines, SOPs and compliance content aligned with US FDA, WHO and other global standards.

Industry

Pharma & Life Sciences

Location

India

Engagement

AI platform build

What we built

Designed and built the complete AI-driven platform architecture: requirement analysis, AI workflow design, prompt engineering, and the document generation engine.

Read more

Built modules for automated SOP creation, guideline generation, template-based formatting, multilingual content support, role-based access, and document review workflows.

Added AI-driven summarisation, contextual recommendations and compliance-oriented document structuring, including intelligent infographic generation, to produce professional regulatory documents with minimal manual effort.

Challenges
  • Aligning generated content with complex, overlapping global regulatory standards
  • Ensuring accuracy, consistency and compliance in AI-generated documents
  • Designing prompts and workflows specific to pharmaceutical regulatory language
  • Generating infographics from regulatory data that were actually accurate, not just decorative
Technologies
  • LLM prompting
  • RAG
  • Python
  • NLP
  • Azure
  • React

The result

Delivered on time, on scope, on budget.

  • Significant reduction in manual effort and document creation time
  • Faster generation of SOPs, guidelines and compliance documents
  • Improved consistency and standardisation across documentation
  • Higher productivity for QA, regulatory and manufacturing teams, with faster access to knowledge

Have a similar problem?

Tell us what you're trying to solve. We'll tell you plainly whether it's a good fit and what it would take.

Or reach us directly at info@ontogenesistechnologies.com · +91-9999101853