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DirectoryRetail & CommerceWholesale - Health & Cosmetic ProductsRotkreuzMateria Medica Maibach AG
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Materia Medica Maibach AG

Summary

About the company

The core activity of Materia Medica Maibach AG is the provision of services in the field of medicinal product authorization and regulation, in particular: Drug Regulatory Affairs (dossier maintenance, expert opinions, technical writing, compliance checks), medicinal product authorization (new authorization, authorization procedures, authorization dossier), Pharmacovigilance (document exchange system, approvals), market authorization and release in Switzerland, wholesale and import of medicinal products into Switzerland. The company acts as a Marketing Authorization Holder and holder of a wholesale license to bring medicinal products to the Swiss market.

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Products & services

Industry:Wholesale - Health & Cosmetic Products
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Medicinal product authorisation
New authorisations, variations, extensions, renewals, transfers and discontinuations of authorisations; scientific assessment, regulatory strategy, authorities meetings and project management.
Regulatory dossier
Creation and update of regulatory dossiers (Modules 1-5), Technical Writing CMC, Medical Writing Nonclinical and Clinical, eCTD and eDOK preparation, reformatting of existing dossiers.
Regulatory consulting and dossier support
DRA Full Support, maintenance measures, review and expert opinions, management consulting, compliance audits, authority correspondence, deadline monitoring and support with eCTD tool evaluation.
eCTD tools and document exchange system
eCTD software, project management software, regulatory tracking database and literature management software as well as MMM DRA-Serv for access to dossier data.
Market access for medicines
Rapid introduction of medicines to the Swiss market with import, wholesale, market release and suitable solutions for Swiss requirements.

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Location

Birkenstrasse 49
6343 Rotkreuz

At a glance

Legal form
Corporation
UID
CHE-113.166.248
Founded
2006 · 20 years
Last commercial register change
November 10, 2015
Employees
1 to 10

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