Sylvia Schuepbach Sylvia Schuepbach

Sample dispatch and sample delivery

A Swiss company with a wholesale license was looking for new solutions for shipping drug samples and drafting internal guidelines for sample distribution to pharmacies and drugstores.

A Swiss company with a wholesale license was looking for new solutions for shipping drug samples and drafting internal guidelines for sample distribution to pharmacies and drugstores.

We supported the company in selecting a transport service provider and drafted contracts to ensure that the transport complies with Good Distribution Practice (GDP) and that the medicines are not damaged.

Together, we drafted internal guidelines (Standard Operating Procedure, SOP) that clearly and simply specify the quantities in which samples for professionals and the general public can be distributed to professionals in drugstores and pharmacies in accordance with the provisions of the Ordinance on the Advertising of Medicinal Products (AWV). This enabled the company to simplify its processes and ensure that samples were distributed in accordance with Swiss law.

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Sylvia Schuepbach Sylvia Schuepbach

Pharmaceutical manufacturing

Legal and technical requirements for manufacturing companies.

A pharmaceutical manufacturer optimized its production processes as part of the expansion of its product portfolio. We supported the quality assurance (QA) and the responsible person (FvP) in the development of the concept in legal and regulatory matters.

Legal and technical requirements for manufacturing companies

A pharmaceutical manufacturer optimised its production processes as part of an expansion of its product portfolio. We supported quality assurance (QA) and the responsible person (FvP) in developing the concept with regard to legal and regulatory issues, ensuring that all product-specific requirements of current good manufacturing practice (cGMP) were taken into account when adapting the quality management system (QMS). For this purpose, we also systematically reviewed internal guidelines (Standard Operating Procedures, SOPs) and compared them with regulatory requirements (guidelines and technical interpretations). This strengthened quality awareness and consolidated quality documentation.

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