ENTERPRISE AI CONSULTING FOR PHARMA, BIOTECH & MEDTECH
Our enterprise consulting guides Swiss pharma, biotech, and MedTech companies in scaling GxP-compliant AI – from Computerized System Validation (CSV / GAMP 5) and audit-ready RAG systems for Veeva Vault to regulatory submissions (Swissmedic, EMA, FDA).
AI means so many things. Which AI do you actually need? What is your specific area of application?
We help - from short-term pilot projects and rapid experiments all the way to enterprise solutions.
Simply streamline daily workflows or transform an entire business unit with autonomous agents? Discover the possibilities with us.
GxP, CSV (GAMP 5), Swissmedic, EMA & FDA
Legal certainty & data sovereignty in Switzerland.
Veeva Vault, SAP S/4HANA & LIMS Integration
Vendor-neutral technology & architecture selection.
EU AI Act, MDR/IVDR & Full IP Protection
Strategy, process automation & custom software.
We combine strategic foresight with industry-specific compliance and technical process implementation.
Deviations, CAPA & SOP Management
Before we install technology, we create clarity.
Submission Dossiers & Evidence Synthesis
Innovation without risk. We make your AI audit-ready.
Scientific Communication & Omnichannel Enablement
This is where value is created. We integrate AI deeply into your value chain.
Structured implementation steps tailored to your industry value chain.
Phase 1: Immediate Leverage
Efficiency gains in regulatory and documentation. Generative AI helps summarize studies and accelerates the approval process.
Phase 2: Process Integration
Optimization of production and supply chain. Machine learning can help detect supply chain anomalies early and support quality control. Expert review remains essential.
Phase 3: Transformation
Transformation of R&D (Research & Development). We integrate tailor-made models for predicting molecular structures and accelerating clinical trials.
We bridge cutting-edge language and analytical models with the strict requirements of QA, Regulatory, and IT Security.
Every generated sentence in a dossier or QA report links directly to document ID, version, and page number.
Clear documentation of intended use, risk classification, test protocols, and audit trails.
Rapid productivity gains in non-GxP workflows alongside controlled deployment of validated GxP pipelines.
Whether a clearly defined project or agile support – you have full cost control.
Maximum Planning Certainty
Ideal when the goal and scope are clearly defined. We agree on a fixed outcome at a fixed price. Scope, milestones, and acceptance criteria are bindingly defined before the project starts. Any changes are coordinated with you before implementation.
Agile Support & Interim
Book our experts flexibly as needed – whether as a strategic advisor for a few hours or as an integral part of your team.
We discuss your goals with you and clarify without obligation where AI has the greatest leverage in your company. Together we define the framework for a potential collaboration.
We analyze your data and processes to uncover concrete automation potentials. We prioritize the use cases that deliver the highest ROI.
Instead of pure theory, we implement a working pilot project in a selected area. This proves measurable value risk-free before larger investments are made.
We roll out the solution, empower your team through training, and establish Swiss FADP-compliant guidelines for sustainable, secure operation.
Research can help identify useful applications. It does not replace testing the outcome in your own business.
Swissmedic, EMA, and FDA (21 CFR Part 11 / EU GMP Annex 11) require computerized systems in GxP environments to provide complete audit trails, risk-based validation under GAMP 5, and mandatory human-in-the-loop sign-off.
For Swiss MedTech and pharma exporters supplying the EU single market, the interplay of the EU AI Act, MDR, and IVDR mandates rigorous technical documentation, ISO 13485 quality management, and post-market surveillance.
We are happy to assist you in consulting on your business processes and within your selected areas of the value chain:
Initial consultation 100% free
Book your free initial consultation now and let's find out together how you can make your processes more efficient with AI.
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