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AI solutions for regulated industries ensuring compliance, reliability, and measurable results.

Solution by NNIT
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Overview

With over 30 years of experience in Life Sciences, NNIT offers AI solutions tailored for highly regulated industries, ensuring compliance, reliability, and measurable business outcomes from roadmap to production. The approach is built on three pillars: Life Science AI Expertise, Responsible & Compliant by Design, and End-to-End AI Consultancy and Services.

Senior data scientists collaborate with subject matter experts in Regulatory, Quality, and Manufacturing to deliver Generative AI and machine learning solutions that align with industry-specific terminology, processes, and compliance requirements. Key solutions include Regulatory GenAI, Quality Document AI, and Manufacturing Analytics.

Every project begins with a focus on AI ethics, EU AI Act, and GxP readiness. The Trusted AI framework provides validation templates, audit trails, and cybersecurity controls to ensure innovation does not compromise compliance. Key solutions in this area include Trusted AI Governance.

The service covers the full AI lifecycle, from readiness assessments and pilot builds to production deployments and continuous validation. Fixed-price packages allow clients to start small and scale as ROI is demonstrated. Key solutions include AI Readiness Navigator, LLMOps Managed Service, and Continuous Model Validation.

AI Use Cases

  • Contract handling – Public Sector: An AI solution for public authorities that identifies old contracts for new negotiations, developed into a chatbot, optimizing and automating contract reviews with security and formality.
  • Patient Safety – AI Advise: Supports healthcare professionals by providing advice on medication use and patient safety, summarizing relevant information based on age and gender.
  • SOP Document Harmonization: Processes SOP documents by collecting and categorizing them, identifying outdated or duplicate documents, and highlighting discrepancies or risks.
  • MBR – Migration tool: Automates the migration of handwritten comments from old Master Batch Record PDFs to updated versions.

The AI consulting service packages facilitate the transition from initial AI discussions to production-grade solutions within 16 weeks, ensuring compliance with the EU AI Act and GxP standards.

Featured Service Journey: The Compliant AI Value Chain

  1. AI Readiness Navigator: A 4-week use case and ROI roadmap.
  2. Data Products: A 6-week process to create a validated data layer.
  3. Agentic AI Foundation: A 4-week development of an Agentic RAG search engine.
  4. Trusted AI: A 6-week EU AI act and Cyber pack.
  5. AI Training & Adoption: An 8-week policy-based enablement.

The service includes a 6-step fixed-price assessment that converts AI curiosity into an ROI-driven, audit-ready action plan, mapping high-value use cases, quantifying ROI, and identifying compliance and data gaps. The result is a clear decision-making framework for AI initiatives.

The cross-platform framework transforms MES, LIMS, and ERP data into GxP-validated, cloud-ready AI data products, creating a governed data lakehouse on platforms like Azure, Databricks, or Snowflake. This setup supports BI, advanced analytics, and GenAI while meeting GxP audit requirements.

The RAG + Agent framework enables plug-and-play AI search across regulated document landscapes, allowing the launch of domain-smart AI agents without extensive setup. It includes data ingestion, knowledge indexing, agent orchestration, and API integration, all delivered with full validation and documentation.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & Compliance
Target user(s)
QA / Regulatory AffairsBioinformatician / Data Scientist
Tag(s)
Quality & Compliance ManagementAI