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Introduction In the pharmaceutical and life sciences sectors, an effective CAPA links five elements: nonconformity, risk, cause, actions, and evidence of effectiveness. If any one of these elements is weak, the process risks becoming nothing more than a collection of administrative tasks: updating an SOP, retraining staff, sending a reminder to the supplier, and closing […]

For many pharmacies, medical, pharmaceutical, and nutraceutical companies, the first half of the year is often marked by new initiatives, organizational changes, the introduction of new products, updates to documentation, and new operational challenges. In day-to-day operations, attention is naturally focused on operational and commercial activities. However, precisely for this reason, certain aspects related to

In the life sciences sector, acquisitions, mergers, investments and international expansion processes require much more in-depth evaluations than in other industries.In the pharmaceutical, biotech, medical devices and healthcare world, in fact, the value of a company does not depend solely on economic or commercial data, but also on the strength of its regulatory system and

Parallel importation of medicines is an issue of great interest to pharmaceutical stakeholders, particularly importers, distributors, and pharmacies operating in an increasingly competitive and regulated environment. In Switzerland, this practice is permitted but subject to strict requirements set by Swissmedic and the federal regulatory framework. Understanding what is actually allowed and what the critical issues

In the Swiss regulatory environment for medical devices and regulated products, the position of Technical Responsible (RT) is central to ensuring compliance with Swissmedic requirements and the safety of products placed on the market. The term Responsible Person is sometimes used as an international reference, but in the Swiss context the correct designation is Responsible

Medical device traceability is now one of the central elements of regulatory compliance in Switzerland. With the entry into force of the new Swiss regulations aligned with the European framework, the Unique Device Identification (UDI) system has become a mandatory tool to ensure unique identification, patient safety and post-marketing surveillance. For manufacturing companies, manufacturers and

In the life sciences sector, quality does not end with the production of the drug. Distribution also plays a crucial role in ensuring that products reach the end patient in a safe, effective and regulatory compliant condition. It is in this context that GDP – Good Distribution Practice, a set of basic requirements for the

The market for nutraceuticals in Switzerland is growing steadily, driven by consumers who are increasingly focused on prevention, wellness, and quality ingredients. However, accessing this market requires a thorough understanding of Swiss regulations, particularly product classification, labeling, and regulatory obligations. This article provides a practical and up-to-date overview designed for nutraceutical companies and supplement manufacturers

A practical approach for pharmacies and life science companies Quality audits are a crucial time for pharmacies, pharmaceutical companies and life science entities. They are not just about demonstrating compliance with regulatory requirements or reference standards, but about verifying the effectiveness of internal processes and the soundness of the management system adopted. Structured and knowledgeable

What the MDR Regulation entails for manufacturers, importers and distributors in Switzerland “Compliance is not an administrative goal, but the foundation of trust in the market.” With the entry into force of Regulation (EU) 2017/745(MDR), the medical device industry has undergone one of the most profound regulatory changes in decades. For Swiss companies-manufacturers, importers, and