AI for Life Sciences.
Delivered by Experts.

Implement AI with confidence

Regulatory Fluency

FDA, EMA, GAMP 5, 21 CFR Part 11, Annex 11, CSV/CSA built into every engagement

Domain Depth

MES, DCS, Historian, batch records, shop floor ops. We speak your language.

AI Expertise

LLMs, predictive models, computer vision, NLP - applied to real manufacturing problems

AI is only as good as the Data behind it

EIS Expertise

Data Collection

EIS Expertise

Data Integrity

EIS Expertise

AI Output

End-to-end AI services for regulated manufacturing

AI Strategy & Roadmap

Identify high-value AI use cases for your manufacturing, quality, and operations. Prioritize by ROI, feasibility, and regulatory risk. Build a phased roadmap aligned to your digital maturity.

Architecture & Data Foundation

Design the data pipelines, integration layers, and infrastructure your AI needs. Leverage existing Historian, MES, and DCS data. Ensure data integrity and ALCOA+ compliance from the ground up.

Implementation & Integration

Build, train, and deploy AI models within your GxP environment. Integrate with existing shop floor systems (MES, SCADA, DCS, Historian). Platform-agnostic approach: we select the right tool for the job.

Validation & Compliance

Validate AI systems per GAMP 5, CSA, and 21 CFR Part 11. Document intended use, risk assessment, and performance qualification. Ensure audit-readiness from first deployment.

Generative AI Enablement

Deploy GenAI for document drafting, deviation analysis, SOP generation, and knowledge management. Establish guardrails, usage policies, and compliance frameworks for LLM adoption in regulated environments.

Governance & Change Management

Build the organizational structures, policies, and training programs to sustain AI at scale. Define model monitoring, retraining triggers, and human-in-the-loop protocols. Drive adoption across your workforce.

AI Use Cases across the manufacturing lifecycle