Pharma & Biotech Quality Consulting in Basel, Switzerland

The Responsible Person (fachtechnisch verantwortliche Person – FvP) is the individual legally accountable for ensuring that pharmaceutical activities comply with applicable Swiss regulatory and GxP requirements, including GMP and GDP.

The RP/FvP acts as the official regulatory contact for Swissmedic, representing the company in quality and compliance matters and ensuring that regulatory expectations are clearly understood, implemented, and maintained.

Beyond formal compliance, the RP/FvP is a trusted partner to company management, supporting informed decision-making and safeguarding the organization’s regulatory credibility and reputation through consistent, transparent, and proportionate quality governance.

Yes. In Switzerland, pharmaceutical trading activities are regulated and generally require a Swissmedic license, which includes the appointment of a Responsible Person (fachtechnisch verantwortliche Person – FvP).

This requirement applies even when medicinal products do not physically pass through Switzerland. Under Swiss regulation, activities such as purchasing, selling, brokering, or otherwise placing medicinal products on the market from a Swiss legal entity are considered regulated activities, regardless of physical product flow.

Switzerland’s regulatory framework is distinctive in its scope and depth. It is designed to ensure clear accountability at the legal-entity level, prevent illegal or unauthorized trading, and reduce the risk of falsified medicines entering legitimate supply chains. At the same time, Swiss authorities fully recognize Switzerland’s role as an international business and tax hub, where companies may establish Swiss affiliates for legitimate strategic and financial reasons.

The regulatory model is therefore not intended to challenge these business structures, but to ensure that appropriate quality governance and regulatory oversight are in place alongside them.

In this context, the RP/FvP acts as the official regulatory contact for Swissmedic, representing the company in quality and compliance matters and ensuring that regulatory expectations are clearly understood and appropriately addressed. For company management, the RP/FvP is a key partner in supporting sound decision-making and protecting the organization’s regulatory credibility and reputation.

With an experienced RP/FvP and a proportionate Quality System in place, these requirements can be implemented pragmatically and efficiently, providing companies with the clarity and serenity needed to operate confidently while remaining fully compliant.

Common GDP inspection findings most often relate to governance, oversight, and alignment between documented systems and actual operations, rather than to the absence of procedures alone.

Typical observations include:

• insufficiently defined or inadequately implemented RP/FvP delegations, resulting in unclear accountability and limited effective oversight,

• gaps in oversight of suppliers and customers, particularly where qualification, monitoring, or quality agreements do not fully reflect the realities of the supply chain,

• misalignment between the licensed scope of activities and how trading or distribution activities are performed in practice, and

• weaknesses in deviation management, temperature excursion handling, and risk-based decision-making.

These findings are frequently linked to an incomplete or fragmented understanding of the end-to-end supply chain. A clear and accurate supply chain mapping—covering products, flows, partners, decision points, and responsibilities—is therefore a critical foundation for GDP compliance and inspection readiness.

Prevention relies on establishing a proportionate GDP Quality System that reflects the company’s real operating model, supported by:

• clearly defined RP/FvP responsibilities and delegations,

• appropriate and risk-based oversight of both suppliers and customers, and

• a licensed scope that accurately mirrors actual activities.

When these elements are in place, GDP compliance becomes sustainable and transparent, and inspections focus on confirming effective governance rather than identifying gaps. This approach provides both regulators and company management with confidence that trading activities are well controlled, compliant, and credible.

Tulia Via reflects both my professional philosophy and my personal roots.

Tulia means serenity in Swahili — a reference to my childhood in Kenya and to the idea of calm, grounded progress.
Via means path or way — a deliberate route forward.

Together, Tulia Via represents a clear and steady path through complexity.

In my work, serenity is not abstract. It is the result of robust, well-designed, and compliant quality systems — systems that work in practice, avoid unnecessary inefficiencies, and stand up confidently to Health Authority expectations.

When processes are clear, fit for purpose, and inspection-ready, teams can focus on their work without constant disruption, last-minute fixes, or regulatory uncertainty. That is the kind of serenity Tulia Via is built to deliver.