Quality Assurance · Swiss Operations
Swiss Operations. Clear FvP Oversight. Practical Quality.
Quality-system and inspection-readiness support for Swiss establishment licensing
Establishing pharmaceutical operations in Switzerland? Make FvP oversight and quality part of the plan.
Discuss your operating model
Setting up or reviewing your Swiss operations?
Tell us briefly where you stand. We will get back to you personally.
Thank you. We have received your request.
[Joanna Hanley or a member of the team will get back to you within X working days.]
Incorporation is only the start.
For pharma and biotech companies establishing a European base in Switzerland, incorporation is only the start. Depending on your activities, such as seeking a Swiss marketing authorization or trading medicinal products in Switzerland or abroad, you may also need a Swissmedic establishment license, FvP oversight and an appropriate QMS.
At Luminance Health, we help build the quality framework for Swiss operations, with clear responsibilities and practical processes. The goal: a license scope aligned with your business, effective FvP oversight and a QMS that works beyond the initial application.
Establishment license
A license scope aligned with your business.
FvP oversight
Qualified, independent oversight of licensed activities.
Quality system
A QMS that works beyond the initial application.
Inspection readiness
Preparation before Swissmedic comes to you.
Products may stay abroad. Swiss quality obligations do not disappear.
Trading between countries outside Switzerland
A Swiss entity trading medicinal products between countries outside Switzerland:
- Needs a Swissmedic establishment license covering trading abroad
- Remains responsible for Swiss quality obligations
- Stays in scope even if products never enter Switzerland
What remains essential
Even for trading abroad, you need:
- Trading-partner qualification
- Product-quality assurance
- Supply-chain oversight
- Effective FvP oversight
From your challenge to a practical solution
We build the quality framework for your Swiss operations, with clear responsibilities and practical processes.
QMS development
Your challenge
You need a quality management system that fits your Swiss activities.
What we do
We develop a QMS that works in practice, beyond the initial application.
- QMS development
- Clear responsibilities
- Practical processes
- Alignment with your license scope
Supplier oversight
Your challenge
You need to be sure that your partners and suppliers meet the requirements.
What we do
We support trading-partner qualification and oversight along your supply chain.
- Trading-partner qualification
- Supplier oversight
- Supply-chain oversight
- Product-quality assurance
Inspection preparation
Your challenge
You want to be ready when an inspection comes.
What we do
We prepare you for inspections, so that processes and responsibilities are in place.
- Inspection preparation
- Review of processes
- Clear responsibilities
- Readiness for establishment licensing
Ongoing quality governance
Your challenge
Your FvP and quality arrangements must stay effective over time.
What we do
We support ongoing quality governance, including your FvP oversight.
- Ongoing quality governance
- FvP oversight
- Review of FvP arrangements
- Authority, resources and involvement for the role
Setting up a Swiss entity, seeking a trading-abroad license or reviewing your FvP and quality arrangements?
Let's discuss your operating model.
Get in touch
Your contact
Joanna Hanley
Head Quality Assurance, Luminance Health
The FvP is more than a name on the license.
Joanna leads in developing and establishing pharmaceutical Quality Management Systems that comply with global regulations, laws and GxP standards. Through her long-standing experience in interpretation and execution of international requirements, she provides pragmatic and tailored QMS solutions to ensure GxP compliance for organizations of all sizes and at all stages of the product life cycle.
Joanna has been named as Responsible Person (RP) on a diverse range of Swiss establishment licenses, including for small molecules, stable blood products, biologics and Advanced Therapy Medicinal Products (ATMPs). Through this experience, she has been responsible for ensuring the safe trading of medicinal products both in Switzerland and abroad.
Joanna has additionally advised organizations on quality compliance and continuous improvement topics through deployment of bespoke training programs and by providing auditor / mock inspector services.
Joanna has substantial scientific expertise in the area of ATMPs and holds a PhD in molecular biology from University College London, where she gained specialized knowledge in viral vector-based gene therapies.
[email address]Frequently asked questions
What is the FvP?
The fachtechnisch verantwortliche Person (FvP) is Switzerland's Responsible Person. The role requires qualified, independent oversight of licensed activities, and the authority, resources and involvement to deliver it.
Do we need a Swiss license if our products never enter Switzerland?
A Swiss entity trading medicinal products between countries outside Switzerland needs a Swissmedic establishment license covering trading abroad. Swiss quality obligations remain, including trading-partner qualification, product-quality assurance and supply-chain oversight.
What can Luminance Health do for us?
We help build the quality framework for Swiss operations: QMS development, supplier oversight, inspection preparation and ongoing quality governance.
Who will I speak with?
Your first conversation is with Joanna Hanley, Head Quality Assurance, or a member of the team. [Confirm]
Is the first conversation binding?
[Confirm: The initial conversation is free and non-binding.]
What happens to my data?
We use your details to respond to your enquiry. You can find more in our privacy policy.
Contact
Let's discuss your Swiss operating model
Tell us where you stand. We will tell you honestly how we can help.
What happens next
Contact us
We read every request personally.
Thank you. We have received your request.
[Joanna Hanley or a member of the team will get back to you within X working days.]