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DirectoryBusiness & Technical ServicesManagement ConsultingZugOMCS Medical GmbH
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OMCS Medical GmbH

Summary

About the company

The company offers services in the field of regulatory compliance and approval of medical devices and pharmaceuticals. The core activities include: Regulatory consulting and strategy development for the approval of medical devices and pharmaceuticals; Support in complying with regulatory requirements and standards (e.g. ISO 13485); Conducting tests, validations, and lifecycle management for medical devices; Translation services for global communication of companies; License management and administration for medical devices and pharmaceuticals; Providing information and support to patients and healthcare providers in decision-making in the healthcare sector. The company supports customers in navigating complex regulatory processes and helps them successfully bring their products to market.

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Products & services

Industry:Management Consulting
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Regulatory consulting for medical devices and IVDs
Regulatory services for medical devices and in-vitro diagnostics, including product registration, product classification, technical documentation, quality management, post-market surveillance and start-up support.
Regulatory consulting for pharmaceuticals
Regulatory services for medicinal products, including product registration, Marketing Authorization Holder, dossier submission, product testing, GMP compliance audit and pharmacovigilance.
Regulatory consulting for cosmetics
Regulatory services for cosmetic products, including product registration and notification, representation, claims assistance, product testing, label review and good manufacturing practice.
Authorized Representative / Responsible Person
Representation services for markets requiring a statutory representative, including authorized representation, importer services and customs clearance for authority communication and market authorisation.
Translation services for regulatory documents
Translation, localisation and proofreading for medical, clinical, pharmaceutical, safety and legal documents, including e-IFU and submission-relevant content.

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Location

Aegeristrasse 5
6300 Zug
Opening hours
Mon
08:00 - 18:00
Tue
08:00 - 18:00
Wed
08:00 - 18:00
Thu
08:00 - 18:00
Fri
08:00 - 00:00
Sat
00:00 - 08:00
Sun
Closed

At a glance

Legal form
Limited Liability Company
UID
CHE-132.539.953
Founded
2021 · 5 years
Last commercial register change
August 27, 2021
Employees
1 to 10

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