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DirectoryBusiness & Technical ServicesManagement ConsultingBaselKAHLITY GmbH
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KAHLITY GmbH

Summary

About the company

Kahlity provides consulting and services to companies in the medical device and pharmaceutical industries, particularly in the areas of quality management, regulatory affairs, auditing, training, and project management. The core activities include: Consulting on the implementation and maintenance of quality management systems, Supporting compliance with regulatory requirements, such as EU-MDR, EU-IVDR, and other relevant regulations, Conducting audits and assessments of quality management systems, Training and educating employees in the areas of quality management, regulatory requirements, and project management, Offering services as an authorized representative and importer for companies outside of Switzerland or Europe, Project management and program management for companies in the medical device and pharmaceutical industries.

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Products & services

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Consulting for medical devices and drug-device combination products
Advisory and support for companies developing drug-device combination products; assistance with regulatory strategy, risk reduction and an efficient path to market launch.
Quality Assurance & Regulatory Affairs Compliance
Creation and remediation of technical documentation to comply with applicable requirements; legacy review and correction of existing documentation to restore conformity.
Audit & Inspection Readiness
Internal audits, supplier audits, gap assessments and mock inspections; risk-based audit programmes, preparation for inspections and improvement of ongoing audit readiness.
Authorized Representation & Importer
Swiss, European and UK representation for legal manufacturers; importer services, communication with authorities and support for audits and inspections.
Training & Capability Building
Tailor-made trainings on audit readiness, EU MDR, AI in quality management systems, regulatory fundamentals, quality culture as well as sustainability and custom trainings.

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Location

Bruderholzallee 53
4059 Basel

At a glance

Legal form
Limited Liability Company
UID
CHE-434.573.187
Founded
2021 · 5 years
Last commercial register change
February 18, 2021
Employees
1 to 10

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