Apply AI across Pharma & Life Sciences with real impact.

From R&D and clinical development to regulatory, medical affairs, pharmacovigilance, quality, manufacturing and AI agents: we help life sciences organisations identify relevant use cases, enable their people and bring AI responsibly into real workflows.

R&D Clinical Development Regulatory Affairs Medical Affairs Pharmacovigilance Quality & Manufacturing
Pharma and life sciences building in Basel
Pharma AI in Practice Use AI where quality, evidence and compliance need to work together.

From scientific information work to controlled AI workflows in regulated processes.

22%

of surveyed life sciences leaders say their organisations have successfully scaled AI. Only 9% report significant returns.

Source: Deloitte 2026
10

joint guiding principles from EMA and FDA define a foundation for Good AI Practice in drug development.

Source: EMA & FDA

AI can support the full medicinal product lifecycle.

EMA and Swissmedic do not treat AI as an isolated tool topic. Applications can span discovery and clinical development through manufacturing, regulatory processes and post-authorisation. The specific context of use is what matters.

01

Research & Discovery

Scientific intelligence, literature, target and molecule knowledge, hypotheses and knowledge access.

02

Clinical Development

Study design, trial operations, protocols, documentation and study knowledge.

03

Regulatory Affairs

Submission content, document comparison, regulatory intelligence and medical writing.

04

Medical Affairs

Scientific exchange, MSL support, medical information and evidence synthesis.

05

Safety & Pharmacovigilance

Case preparation, signal support, literature and structured safety information.

06

Quality & Manufacturing

SOP knowledge, deviations, CAPA, process knowledge, training and manufacturing support.

From information work to controlled AI workflows.

The strongest use cases combine high manual effort with clear data sources, reviewable outputs and defined human oversight. In regulated areas, governance needs to be part of the design from the start.

R&D & Scientific Intelligence
High potential

Scientific & Literature Intelligence

Problem

Scientific knowledge is spread across publications, internal documents, studies and data sources.

AI Approach

AI searches approved sources, synthesises evidence, compares publications and supports structured research questions.

Business Value

Faster access to relevant knowledge and more time for scientific interpretation.

Clinical Development
High potential

Clinical Trial Copilot

Problem

Study teams work with large volumes of protocols, status information, communications and trial documentation.

AI Approach

AI summarises information, supports study-team queries, creates first drafts and helps surface operational risks or open points.

Business Value

Less administrative effort and faster preparation of trial decisions.

Regulatory & Medical Writing
High potential

Regulatory Writing Assistant

Problem

Regulatory documents require extensive research, reuse of approved content, consistency checks and review.

AI Approach

AI prepares controlled first drafts, compares documents, finds relevant sources and supports structured review processes.

Business Value

Faster document preparation with clear expert approval and traceability.

Medical Affairs
Human in the loop

Medical Information & MSL Assistant

Problem

Medical teams need to process scientific questions, publications and insights efficiently without compromising scientific accuracy.

AI Approach

AI structures requests, synthesises approved evidence, drafts responses and consolidates MSL insights.

Business Value

Faster preparation of scientific communication and more time for high-value interactions.

Drug Safety
Controlled workflow

Pharmacovigilance & Safety Support

Problem

Safety teams process large volumes of structured and unstructured information, literature and case context.

AI Approach

AI supports extraction, summarisation, classification and preparation of defined review steps.

Business Value

More efficient case preparation with clear human accountability and quality control.

Quality & Knowledge
Foundational

GxP & SOP Knowledge Assistant

Problem

SOPs, work instructions, policies and quality knowledge are often distributed across systems and documents.

AI Approach

A controlled knowledge assistant answers questions using approved content and shows sources transparently.

Business Value

Faster access to knowledge, more consistent answers and fewer recurring internal questions.

Manufacturing & Quality
High potential

Deviation & CAPA Assistant

Problem

Deviation investigations and CAPA processes require research across historical cases, SOPs, equipment and process data.

AI Approach

AI helps find relevant information, summarise similar cases and prepare structured initial analyses.

Business Value

Faster investigation preparation without automating professional assessment or approval.

Agents & Automation
Emerging

AI Agents for Life Sciences Workflows

Problem

Many processes involve recurring steps across documents, knowledge sources, systems and multiple functions.

AI Approach

Agents orchestrate defined tasks, retrieve information, create drafts, check prerequisites and hand results to specialists.

Business Value

Fewer manual handovers and better orchestrated processes with clear control points.

In life sciences, AI needs a clear context of use.

EMA, FDA and Swissmedic emphasise a risk-based approach across the lifecycle. The closer AI gets to evidence generation, quality, safety or regulatory decision-making, the more important validation, data quality, documentation, human oversight and lifecycle management become.

Specific regulatory requirements depend on the use case, product, process, market and system involved. Our work does not replace legal, regulatory or GxP advice.

Context of Use

The role, purpose, boundaries and permitted use of the AI system should be clearly defined for the specific process.

Data Quality & Provenance

Data sources, quality, provenance, representativeness and potential bias should be appropriately addressed.

Validation & Performance

Validation and performance assessment should be proportionate to risk and intended use.

Human Oversight

Review, approval and accountability remain with people where required by the process and risk profile.

GxP, Security & Privacy

Good Practices, privacy, cybersecurity, access rights and confidentiality need to be built into design and operation. AI Security Testing helps assess attack surfaces in chatbots and agents.

Lifecycle & Documentation

Models, prompts, data sources, changes and controls require appropriate documentation and ongoing monitoring.

Scientific and domain expertise remain essential. AI capability comes on top.

R&D, clinical, regulatory, medical, quality, safety, manufacturing and commercial teams use AI in different contexts. We therefore combine AI literacy with role-specific use cases, approved tools and your organisation's governance requirements.

Workshop team collaborating on AI and enablement
Woman with mask in a healthcare context
Role-based Enablement
R&D Clinical Operations Regulatory Affairs Medical Affairs Drug Safety Quality Manufacturing Commercial & Market Access Leaders AI Champions
01
AI Literacy & Responsible AI

Foundations, opportunities, limitations, data, risks and responsible use in regulated environments.

02
Role-specific Life Sciences Use Cases

Real tasks from R&D, clinical, regulatory, medical, quality, safety or manufacturing.

03
Tools, Prompting & Microsoft Copilot

Productive use of approved tools with practical exercises and safe ways of working.

04
Workflows & Agents

Move from individual prompts to repeatable workflows, knowledge assistants and agentic processes.

05
Adoption, Governance & Scale

Embed champions, standards, governance, measurement and continuous improvement.

From skills and use cases to governance and execution.

Depending on where you are today, we can start with enablement, a concrete use case, Microsoft Copilot or a strategic question. The goal is a pragmatic starting point that brings business value, risk and scalability together.

People

AI Enablement & Training

Role-based AI training with life sciences examples, real tasks and clear guardrails.

Corporate AI Training →
Opportunities

AI Use Case Discovery

Identify use cases across the product lifecycle and prioritise them by value, feasibility, data readiness and risk.

AI Use Case Workshop →
Productivity

Microsoft Copilot

Readiness, governance, role-based use cases, training and adoption for safe productivity with Copilot.

Microsoft Copilot →
Organisation

AI Advisory & Governance

Shape strategy, operating model, AI governance, portfolio management and adoption for scalable use.

AI Advisory →
Execution

AI Agents & Workflows

Prototype prioritised workflows, test feasibility and turn them into controlled AI assistants or agents.

Practical AI experience across pharma and healthcare.

Our experience spans AI enablement and prompting through use case discovery and transformation in regulated and knowledge-intensive organisations.

17'000+ people trained
150+ clients
Since 2019 AI Enablement & Transformation
mepha | teva

AI Enablement & Practical Prompting

Practical insights into generative AI, prompting, model limitations and ethical considerations for employees in a pharmaceutical environment.

Healthcare & Medical

Spital Thurgau · KSW

Experience with organisations in healthcare and medical environments complements our work with life sciences companies.

Team Experience

Pharma Project Experience

The team's background includes previous project work in pharma at Bayer alongside long-standing AI product and transformation experience.

Customer logos from the current pharma page.

We integrated the visible client references from the existing page into the new layout.

Common questions about AI in pharma and life sciences.

Which AI use cases are particularly relevant in pharma and life sciences?

Relevant applications range from scientific intelligence, clinical development and regulatory writing to medical affairs, pharmacovigilance, quality, manufacturing, knowledge assistants and agentic workflows. The right use cases depend on business value, data, risk, validation needs and organisational readiness.

How can AI support regulatory affairs and medical writing?

AI can search approved content and sources, compare documents, prepare first drafts and support consistency checks. Expert review and approval remain central, particularly for regulatory content.

How can AI support medical affairs?

AI can structure scientific literature and approved evidence, prepare medical information requests, consolidate MSL insights and summarise scientific content. Scientific accuracy and human review are particularly important.

What role can AI play in clinical development?

AI can support study teams with information access, trial operations, documentation, protocol work and preparation of operational decisions. Applications that influence regulatory evidence require an appropriately controlled and risk-based approach.

Can AI be used in quality and GxP processes?

Yes, for example for access to SOP knowledge, preparation of deviation investigations or finding similar historical cases. The specific application needs to fit GxP requirements, validation, data integrity and the defined context of use.

What matters for AI governance in life sciences?

Important topics include context of use, data quality, provenance, validation, performance, human oversight, GxP, privacy, cybersecurity, documentation and lifecycle management.

Which AI skills do life sciences teams need?

Alongside domain expertise, AI literacy, safe use of approved tools, prompting, critical assessment of AI outputs and an understanding of data, risk, sources and human oversight are becoming increasingly important.

How should a pharma company get started with AI?

A practical starting point combines clear business goals with a prioritised set of concrete use cases. Data, regulatory context, skills, governance and technical conditions should be assessed in parallel. Not every use case needs to become fully automated or production-ready immediately.

Where can AI create the greatest value in your life sciences organisation?

Tell us briefly where you are today. We will help you assess relevant use cases, capability needs, governance questions and the right next step.

Nina Habicht
Nina Habicht Founder & CEO · Dreamleap Book an Intro Call