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DirectoryBusiness & Technical ServicesManagement ConsultingChamRegTrac GmbH
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RegTrac GmbH

Summary

About the company

RegTrac GmbH provides regulatory consultancy services for the healthcare sector, with a focus on medical devices and consumer healthcare. The company offers regulatory compliance support, intelligence-driven submissions, product registrations, quality management system services, labelling/artwork and post-market surveillance.

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Products & services

Industry:Management Consulting
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Regulatory Consulting for Medical Devices
Regulatory strategy, quality management, technical documentation, CE marking, EU MDR and IVDR compliance, US FDA submissions, PMS, risk management and global product registrations.
Regulatory Consulting for Cosmetics and Consumer Healthcare
PIF preparation, product notifications, claims support, claims substantiation, and labelling and artwork for cosmetic and consumer healthcare products.
Authorised Representative and Responsible Person Services
Authorised representative and responsible person services for MedTech and cosmetics in the UK, EU and Switzerland, including registrations, authority liaison, vigilance and document review.
Regulatory Training and Mentoring
Flexible regulatory affairs training and mentoring via Microsoft Teams for beginners and professionals, with certification support and topic-specific learning packages.
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Location

Gewerbestrasse 5
6330 Cham

At a glance

Legal form
Limited Liability Company
UID
CHE-292.519.647
Founded
2025 · 1 year
Last commercial register change
May 30, 2025
Employees
1 to 10

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