Medical innovations
change lives.
However, the process of turning an idea into an application is often complex and challenging.
- Your time to market is delayed by stringent quality and regulatory requirements.
- Time and precision are required for clinical trials and proof of efficacy.
- Globalizing your solutions requires experience and reliable partners.
Vysyo removes these hurdles.
We bring innovations to market safely and efficiently.
- We ensure compliance with medical and regulatory standards.
- We generate compelling clinical impact and risk data.
- We guide your global launch every step of the way.
Driven by our clients’ passion for medical progress, we help you focus on what you do best:
Providing safe and effective healthcare to people around the world.
‘Medicine is always international. Its products should be too. This is not only because their commitment should pay off, but also because I believe that as many patients as possible around the world should benefit from good medicines and products.’
Dr. Kai Ulf Markus
‘Medicine is always international. Its products should be too. This is not only because their commitment should pay off, but also because I believe that as many patients as possible around the world should benefit from good medicines and products.’
Dr. Kai Ulf Markus
What are the advantages of working with us?
All of our team members are experienced…
- from medicine, medical science or related industries.
- with the development of products and medicines.
- manufacturing products and medicines.
- with the approval and distribution of products and medicines.
We understand the demands of highly competitive, conservative and price-sensitive global medical care markets.
Our team includes physicians, engineers and biotechnologists
Outsourcing of QM and RA activities
Why Vysyo? Why outsourcing?
Is your company’s core area really licensing, QM and regulatory compliance?
The market is becoming increasingly complex and heavily regulated, with all the associated pros and cons. We do not view this negatively: regulations in the healthcare sector often provide greater security and, above all, establish objective benchmarks for your portfolio’s performance.
What has long been standard practice in many successful companies is also increasingly true of quality and regulation: the best companies focus on their core business and outsource everything else to proven experts.
In particular, our most innovative and agile customers rely on us — a powerful team of experienced professionals who support them competently and efficiently, on an equal footing.
Here are eight compelling reasons to work with us:
Regulatory affairs that make a difference: Vysyo helps you to navigate national and international requirements safely, designing efficient, clear and targeted approval processes to give you direct market access.
Strategy with vision: We support you beyond the approval stage, providing well-thought-out planning, networked thinking and a clear roadmap for your products, covering pricing, reimbursement and strategic marketing.
QM that works: We develop lean, audit-proof quality management systems that are perfectly tailored to your processes, ensuring maximum acceptance and test reliability.
Confidently through every audit: Whether it’s an inspection or a partner audit, with Vysyo you will be optimally prepared and able to present your company to the outside world with confidence.
Reach your goal faster: With Vysyo, you can save time, resources and stress thanks to accelerated processes, fewer errors and faster market entry.
Approval and reimbursement are key to success. We start with regulatory support and also provide pricing, reimbursement and health economics support to ensure long-term market success.
Solutions tailored to you: No standard solutions, no copy-and-paste. We offer customised concepts that are perfectly tailored to your products, structures, and challenges.
Reliability that lasts: Vysyo is not just a service provider — we are your long-term partner. We are transparent and solution-oriented, and we always work with you at eye level, using our heart, mind and experience.
SERVICES
