Pharmaceutical production

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 with regard to legal and regulatory issues. The aim was to ensure that all requirements of current good manufacturing practice (cGMP) were taken into account when adapting the quality management system (QMS) for specific products. To this end, we also systematically reviewed internal guidelines (standard operating procedures, SOPs) and compared them with official requirements (guidelines and technical interpretations). This strengthened quality awareness and consolidated quality documentation.

Grüezi Schwiiz / Hello Switzerland

Gaining a foothold in the Swiss pharmaceutical market with customized solutions

An EU marketing authorization holder of various medicinal products has decided to establish itself in Switzerland. The provision of the medicinal products on the Swiss market had previously been carried out by regulatory third-party providers on its behalf. We provided legal advice on the transfer of the Swiss marketing authorizations and the granting of all operating licences and, in particular, also arranged the replacement of the contracts. Together, we were able to plan and successfully implement optimal solutions for the specific group structure, thereby laying the foundation for independent business activities in Switzerland.