Entering the European Market. Regulatory-smart and commercially successful.
For many companies outside Europe, the European market is an attractive destination — especially Germany, which has one of the largest and most demanding healthcare markets in the world.
The path to market entry in Europe is complex. We’ll pave the way for your medicinal product, medical device, food supplement, or cosmetic product.
Without in-depth knowledge of the regulatory requirements, the right type of market access, and the necessary local structures, market entry often fails before it even gets off the ground. With nearly 40 years of experience in market launches, we know how to get you on the right path.
Every successful project begins with constructive dialogue.
have been supported by Diapharm in recent years — by building systems, obtaining authorizations, maintaining registrations, or assuming regulatory responsibilities.
We lay the foundation for market success.
is the current record for marketing authorization applications in which Diapharm has acted as applicant and marketing authorization holder, managing the entire process.
We know how to handle complexity.
have been developed based on Diapharm’s dossiers and successfully launched in nearly all European markets.
We know what the market needs.
Market Insight
Diapharm combines strategic business consulting with regulatory expertise.
Consulting on European market entry – with a focus on Germany as your strategic gateway. Companies looking to enter this market need a realistic and legally sound market entry strategy that enables them to achieve their business goals efficiently.
So what does it take?
1. Strategic Planning for Market Access
We assess your products, objectives and operating conditions — and build a pragmatic, reliable market entry strategy. In doing so, we take regulatory requirements and the long-term feasibility of your project into account. You’ll receive a comprehensive overview of the necessary steps.
2. Regulatory Feasibility Analysis & Roadmap
What approvals are required? What roles must be appointed? What are the authorities really looking for? We provide clear answers and actionable solutions. If requested, we can assume key roles in the approval process, taking full regulatory responsibility for medical devices in accordance with MDR or pharmacovigilance requirements in the pharmaceutical sector. The completed roadmap provides the timeline for your process workflow.
3. Implementation Support
We provide advice and implementation: from assuming regulatory responsibilities to handling communication with the authorities. This also includes taking responsibility as an EU authorized representative for medical devices or as the legal authorization holder — reliably, transparently, and in accordance with all regulatory requirements. We’ll take responsibility, so you don’t have to.
4. Local Structures
Structures within your own company don’t always make sense, which is why we provide quality management systems for pharmaceuticals and medical devices within our own authorizations — taking full regulatory responsibility and clearly defined liability. This frees you up for what matters most.
5. Cultural and Practical Market Insight
Not only do we understand the legal framework, we know the real-world dynamics of the European market — a key factor for successful positioning. Our experience with medical product approvals and medical device conformity procedures is a key reason for our success. You’ll benefit from our experience.
6. Forward-Thinking Consulting
We understand both regulatory demands and business goals — and we bring these perspectives together through strategic focus, pragmatic thinking and a results-driven approach. We show you how to sustainably move forward after you’ve achieved market entry.
