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© 2026 cohaga AG · All Rights Reserved · St. Gallen, Switzerland · Imprint745,194 companies indexed · Last updated: today
DirectoryBusiness & Technical ServicesManagement ConsultingBernRegulix GmbH
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Regulix GmbH

Summary

About the company

The core activity of Regulix LTD is to provide services in the field of regulatory affairs for the pharmaceutical industry, including: consulting and support for regulatory projects, eCTD compilation (electronic submission of authorization applications), GMP compliance (Good Manufacturing Practice), safety data management, project management and expert support for fulfilling regulatory requirements. The company offers these services to support customers in meeting regulatory requirements and helping them achieve their goals within reasonable timeframes.

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Regulatory Affairs consulting
Regulatory strategies, preparation of authorisation documentation, clinical trial applications and post-authorisation dossiers, and interaction with authorities.
Project management and project support
Project management or support for development and facility projects, with external manpower for small and large initiatives.
Authorisation documentation and eCTD compilation
Preparation of documentation for marketing authorisations in Switzerland, the EU, the USA and Canada, including eCTD compilation.
Clinical trial applications
Preparation of applications for clinical studies, including IMPDs and INDs.
Post-authorisation dossiers
Preparation of documents for variations, renewals, labelling changes and review letters after authorisation.
Reimbursement applications for Switzerland
Preparation and submission of reimbursement applications for the Swiss market.
Regulatory authority communication
Any interaction with regulatory authorities, as well as clarifications on applicable laws and guidelines.
Translations of medical and technical documentation
Translation services for medical and technical documents in English, German and French.
Quality management support
Technical support in the field of quality management for regulated products and projects.
Responsible Person (QP / FvP)
Assumption of the role of Responsible Person for the Swiss market.
Safety Data Management
Management and administration of safety data in the regulatory environment.
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Location

Effingerstrasse 6a
3011 Bern

At a glance

Legal form
Limited Liability Company
UID
CHE-109.382.984
Founded
2001 · 25 years
Last commercial register change
February 3, 2026
Employees
1 to 10

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