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We are committed to our values of trust, respect and excellence

GROW YOUR BUSINESS

OUR SERVICES

Intro

MEDICAL DEVICE & DRUG-DEVICE COMBINATION ADVISORY SUPPORT

We provide support to companies developing drug-device combination products

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We enable our clients to identify the most efficient and cost effective approach, while reducing risk of delays to time-to-market

QUALITY ASSURANCE & REGULATORY AFFAIRS COMPLIANCE

We help you to build or remediate your technical file in compliance with applicable requirements.

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We perform legacy review and remediation activities to bring back your technical documentation into compliance.

AUDIT & INSPECTION READINESS

We conduct internal audits of specific processes, or your full Quality Management System.​

 

We help you to establish your supplier handling process, and qualify your new suppliers, or evaluate your existing suppliers. 

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TRAINING & CAPABILITY BUILDING

Our consultants have experience in offering trainings on behalf of Notified Bodies or at Universities. 

 

Our trainings are focused on auditing management systems, EU-MDR requirements, Business Leadership or Sustainable Resource Performance.

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We also offer on-demand trainings, fully tailored to your needs.

AUTHORIZED REPRESENTATIVES

We offer Swiss Authorized Representative Services for Legal Manufacturers outside Switzerland.

 

We offer European Authorized Representative Services for Legal Manufacturers outside Europe.

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We offer Importer Services for Legal Manufacturers outside Switzerland or Europe​​

ARTIFICIAL INTELLIGENCE INTEGRATION & GOVERNANCE

We provide guidance and support to companies developing embedded AI in medical devices.

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We help navigate the regulatory and development complexities, while keeping abreast of changes in this rapidly developing ecosystem

Réunion des employés

ABOUT US

We are a team of dynamic consultants with a proven track record for managing projects and providing consulting services to companies within the medical devices and pharmaceutical industries. 

THEY TALK ABOUT US

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International Life Sciences Awards 2022

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KAHLITY is the "Best Pharmaceutical & Medical Device Consultancy - Northwest Switzerland"

Contact

CONTACT

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