In-country representation for the EU, CH, UK, and USA
Regulatory certainty and market access in all major markets with only one point of contact as the authorized representative
One Partner for All Markets
Save yourself the hassle of coordinating multiple authorized representatives. We are your single point of contact for Europe, Switzerland, the United Kingdom, and the United States.
Decades of Expertise
Benefit from our extensive experience with hundreds of manufacturers. We are familiar with the regulatory requirements in detail and avoid typical pitfalls from the outset.
Guaranteed Reachability
No need to worry about sick leave, vacation coverage, or time zones: Our global team of experts is available during your business hours – even on holidays.
Direct Access to Top Experts
Benefit from the included monthly 30-minute expert consultation for quick solutions and optimal approval strategies.
Comprehensive Regulatory Support
From approval to quality management and post-market surveillance: Our experts support you in mastering all regulatory challenges.
Cost Efficiency
Save costs with our one-time inspection of the approval documents for all target markets and efficient coordination from a single source.
Being successful in international markets without a local presence – thanks to the right partner as, for example, an EU or CH representative
As a regulatory affairs manager, you are faced with the complex task of finding and coordinating reliable authorized representatives for various international markets.
Finding competent partners is time-consuming, the selection process is risky, and coordinating several authorized representatives is costly.
The wrong partner can lead to delayed market approvals – and thus to significant revenue losses for your company.
Everything from a single source: We are your reliable authorized representative for medical devices in Europe, Switzerland, the United Kingdom, and the United States
As your official authorized representative, we take on:
- Responsibility as a regulatory experienced local contact for authorities
- Compliant inspection of the completeness of your regulatory documents by our experienced MDSAP auditors
- Coordination of all necessary processes for market approval
- A monthly 30-minute expert consultation on the optimal approval strategy
We are your reliable partner for your successful market access in the USA and take on the legally compliant communication with the FDA as your US Agent.
Start your journey into new markets now!
Contact us right away.
WWe will analyze your situation and show you the fastest way to successful market approval.
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