Regulatory Affairs · Switzerland
Planning for Success from the Start
A purposeful, integrated regulatory pathway for life sciences and med tech companies entering or expanding in Switzerland
Regulatory strategy should start with the end in mind: a commercially viable product and a clear pathway to get there.
Discuss your regulatory strategy
Planning your Swiss regulatory pathway?
Tell us briefly where you stand. We will get back to you personally.
Thank you. We have received your request.
[Karoline Hahn or a member of the team will get back to you within X working days.]
The goal is not simply to reach approval.
It is to create the right evidence, make the right decisions at the right time, and build a product with a commercially viable path from development to market.
At Luminance Health, regulatory strategy is not treated as a sequence of submissions and interactions. Instead, we plan for success by helping you build a purposeful, integrated pathway in which scientific advice, Swissmedic engagement, dossier strategy and lifecycle planning support informed decisions at every stage of development.
Scientific advice
Informed decisions at every stage of development.
Swissmedic engagement
Interactions that are planned as part of one pathway.
Dossier strategy
Dossiers that follow a clear strategy from the start.
Lifecycle planning
A pathway that reaches beyond the first approval.
Design the pathway intentionally, from the very beginning
A sequence of submissions and interactions
Without an integrated pathway, companies may face:
- Development choices that are disconnected from commercial viability
- Risks that are identified late
- Resources that are not focused where they create the most value
Planning for success
Connecting development choices, CMC strategy and regulatory requirements with:
- Commercial viability
- Early risk reduction
- Investment discipline
- Clear decision gates and go/no-go points
From your challenge to a practical solution
We connect development choices, CMC strategy and regulatory requirements with a commercially viable path from development to market.
Scientific advice
Your challenge
You need to make informed decisions at every stage of development.
What we do
We help you use scientific advice as part of one integrated pathway.
- Informed decisions at each stage
- Link to development choices
- Link to CMC strategy
- Testing of assumptions
Swissmedic engagement
Your challenge
You need to engage with Swissmedic in a planned and purposeful way.
What we do
We plan the interactions with Swissmedic as part of your overall pathway.
- Planned interactions
- Alignment with your pathway
- Preparation of key questions
- Regulatory requirements understood early
Dossier strategy
Your challenge
Your dossier has to support both approval and a viable product.
What we do
We develop the dossier strategy together with your development and CMC choices.
- Dossier strategy
- CMC strategy
- Regulatory requirements
- Evidence that fits the pathway
Lifecycle planning
Your challenge
You need a pathway that holds beyond the first approval.
What we do
We support lifecycle planning so that decisions stay informed at every stage.
- Lifecycle planning
- Decision gates
- Go/no-go points
- Focus of resources where they create most value
Your contact
Karoline Hahn
Head Regulatory Affairs, Luminance Health
The goal is not simply to reach approval. It is to create the right evidence, make the right decisions at the right time.
Karoline is Head Regulatory Affairs at Luminance Health. Karoline delivers strategic, purpose-driven regulatory guidance that accelerates global drug development. With extensive knowledge of international regulatory frameworks, she provides actionable advice that helps biopharma companies navigate complex development pathways, from early-phase planning through submission and post-marketing compliance.
Karoline partners closely with cross-functional teams to align regulatory objectives with commercial goals and drive timely approvals. Her deep understanding of global regulatory expectations enables her to anticipate challenges, identify opportunities, and shape regulatory positioning that supports both scientific integrity and market success.
Karoline is a recognized expert for Advanced Therapy Medicinal Products, offering strategic, results-driven guidance in this highly complex and evolving field. In previous roles, she has supported companies across multiple therapeutic areas and development stages.
Karoline acquired a PhD in molecular biology from the University of Cologne, Germany, investigating plant-pathogen interactions under supervision of the Max-Planck-Institute, Cologne. Before joining the pharma sector, Karoline worked as a scientist at research institutes and universities in France, Finland, Germany, and Italy.
[email address]Frequently asked questions
When should we start planning our regulatory strategy?
At the very beginning. Regulatory strategy should start with the end in mind: a commercially viable product and a clear pathway to get there.
What can Luminance Health do for us?
We help you build a purposeful, integrated regulatory pathway: scientific advice, Swissmedic engagement, dossier strategy and lifecycle planning, connected with commercial viability, early risk reduction and investment discipline.
Who will I speak with?
Your first conversation is with Karoline Hahn, Head Regulatory Affairs, 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 regulatory strategy
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.
[Karoline Hahn or a member of the team will get back to you within X working days.]