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DirectoryBusiness & Technical ServicesManagement ConsultingRotkreuzEUDRAC AG
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EUDRAC AG

Summary

About the company

EUDRAC AG is a European specialised regulatory affairs and pharmacovigilance consultancy that supports clients through product development, marketing-authorisation applications (MAA), market launch and post-authorisation activities across EU countries. Services include dossier writing and submission, pharmacovigilance services, audit/inspection support and regulatory advice for medical devices and nutritional supplements.

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Regulatory Affairs and Pharmacovigilance Consulting
Regulatory affairs and pharmacovigilance consultancy for medicinal products, supporting development, registration, market launch and post-approval activities in EU countries.
Marketing Authorisation Applications (MAA)
Support throughout the entire MAA process, including preparation, review and submission of the required modules, as well as guidance through the assessments up to approval.
Scientific Dossier Writing
Scientific dossiers for medicinal products, including information on safety, efficacy, quality and manufacturing; preparation in CTD format for central, national, MRP and DCP procedures.
Pharmacovigilance Services
Pre- and post-marketing pharmacovigilance, including intelligence reviews, training and support for audits and inspections to ensure regulatory compliance.
Variations, Renewals, MA transfer
Post-authorisation support for medicinal products: variations, renewals and transfer of the marketing authorisation with regulatorily controlled procedures.
CE Mark
CE marking for medical devices, including support with conformity assessment, technical documentation, quality management system and lifecycle compliance.
Technical Files
Technical files for medical devices with documentation for CE marking, along with support throughout the product lifecycle and for regulatory requirements.
Regulatory overview for Nutritional Supplements
Regulatory categorisation of food supplements and nutraceuticals, focusing on classification, notification, labelling and country-specific requirements.
Training
Training in regulatory affairs, pharmacovigilance, global development and project management for medicinal products, cosmetics, medical devices and food supplements.
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Location

Binzmühlestrasse 14
6343 Rotkreuz

At a glance

Legal form
Corporation
UID
CHE-195.076.781
Founded
2023 · 3 years
Last commercial register change
October 4, 2023
Employees
1 to 10

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