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DirectoryBusiness & Technical ServicesManagement ConsultingGenevaPharmadossiers Sàrl
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Pharmadossiers Sàrl

Summary

About the company

The core activity of Pharmadossiers is to provide services in the field of regulatory affairs for the pharmaceutical industry, particularly in Switzerland. This includes: * Preparing and submitting marketing authorization applications for pharmaceutical products and medical devices to the Swiss authorities (SwissMédic and OFSP) * Developing and implementing regulatory strategies to obtain market approvals * Creating documentation for the authorization and distribution of medicinal products and medical devices * Supporting price negotiations with Swiss health authorities and health insurance companies * Advising and supporting compliance with quality standards and regulatory requirements (GxP) The company supports its customers in launching medicinal products and medical devices in Switzerland and offers comprehensive services in the field of regulatory affairs.

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Regulatory Affairs
Registration of human and veterinary medicinal products and medical devices with Swissmedic, dossiers for NCEs and generics, submissions to authorities and marketing approvals.
Quality Assurance & Control
Development of GxP documentation such as Site Master File and SOPs, preparation for inspections, coaching of the quality team and support with GxP authorisations.
Market Access
Preparation of dossiers for reimbursement and access, support with product recognition by the OFSP as well as with price negotiations with authorities and health insurers.

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Location

Boulevard de Saint-Georges 36
1205 Geneva

At a glance

Legal form
Limited Liability Company
UID
CHE-113.606.885
Founded
1987 · 39 years
Last commercial register change
August 15, 2024
Employees
1 to 10

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