Pharmaceutical manufacturing

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.

Grüezi Schwiiz / Hello Switzerland

Gaining a foothold in the Swiss pharmaceutical market with customised solutions

An EU marketing authorisation holder for various medicinal products has decided to establish itself in Switzerland. Until now, third-party providers had been responsible for supplying the medicinal products to the Swiss market on its behalf. We provided legal support for the transfer of Swiss marketing authorisations and the granting of all operating licences, and in particular also structured the orderly termination and replacement of the existing contractual arrangements. Together, we planned and successfully implemented solutions tailored to the group’s specific structure, thereby laying the foundation for the company’s independent business operations in Switzerland.