Accelerate Regulatory Affairs, Clinical Operations, Pharmacovigilance, and Quality Management with GxP-compliant Enterprise AI – integrated with Veeva Vault, SAP S/4HANA, and LIMS in line with Swissmedic, EMA, FDA, and GAMP 5 standards.
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.
ACT NOW
Across pharma, biotech, and MedTech, time-to-market, data integrity (ALCOA+), and rigorous GxP compliance are mission-critical. We help your organization deploy validated AI systems (CSV under GAMP 5) for regulatory submissions, SOP management, and clinical operations – fully aligned with Swissmedic, EMA, FDA (21 CFR Part 11), the EU AI Act, and the Swiss FADP.
AI predicts molecular structures and drastically shortens the early research phase.
Better patient selection and faster analysis of study data through predictive algorithms.
AI checks documents for compliance with strict pharmaceutical regulations (e.g., FDA, EMA).
Avoidance of expensive production downtimes in biotech manufacturing.
In the Swiss pharma, biotech, and medtech industry (Basel, Zug, Zurich, Lake Geneva), we combine AI with uncompromising GxP compliance, Computerized Systems Validation (CSV), and strict IP protection.
Citation-backed RAG systems built on Veeva Vault and TrackWise to accelerate deviation reports, CAPAs, change controls, and SOP updates in alignment with EU Annex 11 and FDA 21 CFR Part 11.
AI-assisted pre-structuring of regulatory dossiers (eCTD), Clinical Study Reports (CSRs), SmPCs, and Swissmedic/EMA/FDA authority responses with full source traceability.
Deployment of AI pipelines in dedicated Swiss or on-premise environments to safeguard molecular, patent, clinical trial, and CMC manufacturing data.
Training empowers your team to use AI independently in their daily work. Our consulting, on the other hand, guides you strategically from potential analysis to company-wide integration.
Practical workshops and seminars where your team learns the productive and secure use of AI tools in their daily work – including data protection guidelines and immediately applicable templates.
From potential analysis to an individual roadmap: We provide strategic advice on quick wins, governance, and compliance, and support you during secure AI integration.
Simply contact us for a no-obligation initial consultation.
Free Initial ConsultationResearch 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:
We are happy to support you in analyzing and optimizing your business processes in the areas of your choice.
Learn more
