Pharmaceutical

A Natural Fit for Pharma and BioTech

The pharmaceutical industry is on a digital transformation journey. Missed insights from clinical data, complex regulatory frameworks, and faster innovation cycles drive companies to turn to Artificial Intelligence (AI)—particularly Agentic, Large Language models (LLMs) and Generative AI. These tools show great promise, but using them in pharmaceutical processes has significant challenges.

Regulatory pressure: All systems must be GxP-validated, explainable, and auditable. Black-box AI outputs are difficult to justify to regulators.

Complex scientific language: Biomedical terminology, acronyms, and evolving ontologies challenge generic AI models unsuited for the domain.

Data fragmentation: Knowledge is scattered across R&D reports, regulatory submissions, clinical trial protocols, and pharmacovigilance records.

Trust and accuracy: Even minor misinterpretations can have serious compliance or patient safety implications.

Integration barriers: Embedding new AI into legacy validated systems is costly and slow.

Why is expert.ai different

expert.ai’s hybrid approach blends mature symbolic reasoning (rules, ontologies, knowledge graphs) with machine learning. The results are a more accurate and less costly way forward for pharma and BioTech firms. expert.ai moves beyond simple, rule-based automation to support agentic systems that reason, learn, and adapt to the complex, highly regulated life sciences sector.

Explainability: Transparent, rule-based reasoning regulators and scientists can trust.
Accuracy: Proven handling of domain-specific biomedical semantics.
Consistency: Reliable, repeatable results that support validation and audit trails.
Governance: Alignment with GxP standards and regulatory compliance requirements.

This makes hybrid AI especially suited for expensive long-term clinical trials and quality control in pharma manufacturing, where reliability and compliance cannot be compromised.

Proven Uses of Hybrid AI

expert.ai already adds value with Hybrid AI in pharmaceutical and BioTech firms across the US and Europe. Proven, Ready to Go,  Native to Australia

Pharmacovigilance

Automating adverse event detection and reporting from medical records, call centre notes, and patient feedback.

Clinical Trial Intelligence

Extracting patient eligibility criteria, outcomes, and safety signals from trial protocols and reports.

Regulatory Submission Automation

 Structuring and validating documents for FDA/EMA/TGA submissions with traceable semantic tagging.

R&D Knowledge Mining

Identifying drug-target interactions and synthesising insights from scientific literature and patents.

Manufacturing Quality & Compliance

 Monitoring deviations, CAPA documentation, and SOP adherence across production environments.

Medical Affairs & Labelling

Ensuring drug labelling and promotional materials are accurate, compliant, and aligned with regulatory guidance.

Ontology and Taxonomy Management

Harmonising biomedical vocabularies across research, clinical, and regulatory domains

Where LLMs Add Value

Behind the results of Generative AI are large language models that perform heavy-lift computations for creative and exploratory tasks. LLMs complement hybrid AI to accelerate human productivity and insight generation.

Drafting literature reviews and research summaries.
Simplifying complex findings for non-specialist audiences.
Supporting brainstorming by suggesting hypotheses or connections.
Enabling conversational search for rapid knowledge discovery.

FOMO? We have the Answer!

For pharmaceutical companies, the choice is not between Hybrid AI, LLMs and generative AI—it is about using them together in the right way. Hybrid AI provides the trusted, explainable foundation required for regulated industries, while LLMs add agility and communication smarts.

The winners will have AI strategies grounded
in compliance and explainability of Generative AI.

Hybrid AI isn’t just the more intelligent choice; it’s the necessary one.

Why Choose expert.ai
Out-of-the-Box Solutions?

Accelerated Time-to-Value

Launch your AI initiatives in weeks, not months. Proven pre-built solutions significantly reduce the time and resources needed to get up and running.

Unmatched Accuracy

Hybrid AI technology, combining symbolic and machine learning approaches, ensures a deeper, more accurate understanding of your data from the start.

Ready for Customisation

While our solutions are ready to go, they are not black boxes. They provide a solid foundation that can be easily customised to fit your unique business processes and data, giving you the best of both worlds.