Expertise.
International market access.
Reach global markets efficiently with customized support for regulatory requirements.
Complex?
Are regulatory requirements a challenge for international markets?
Compliant?
Do your products reliably meet all global regulatory requirements?
On time?
Do your products reach new markets on time and without delay?
Secure global market access - compliant, clear and on time.
We guide you safely through complex regulatory requirements for your international market entry.
The launch of products on international markets is associated with complex regulatory requirements that pose major challenges for many companies. Our experts will help you to meet these requirements safely and thus efficiently manage your global market entry.
To ensure that your products are always compliant, we provide full regulatory advice, including the preparation of all relevant technical documents and proactive communication with authorities. Our comprehensive expertise helps you to identify and avoid regulatory risks at an early stage.
We also develop strategies that enable you to launch your products on time. Through precise planning and implementation of regulatory processes, we ensure that your products are available on time and without delays in the target markets.
Take advantage of our expertise for successful global market access.
Global Market Access Services at a glance.
Our Global Market Access Services cover all aspects required for successful entry into international markets.
Regulatory advice.
- Support with MDR, FDA and international regulations
- Communication with authorities and notified bodies
- Advice on local requirements and certifications
Market launch strategy.
- Development of market entry strategies for various countries
- Identification of market risks and opportunities
- Support with the planning and implementation of the market launch
Technical documentation.
- Preparation and submission of approval documents
- Ensuring compliance with regulatory requirements
- Maintaining and updating documentation in the event of regulatory changes
Successful market launches on global markets.
Our Global Market Access projects help companies to fulfill regulatory requirements and successfully place their products on international markets.
Market access for a medical technology company in the USA
Global market access for a biotechnology company
Regulatory support for market entry in Europe
Challenge.
A medical device company needed to secure FDA approval for a new product in order to enter the US market.Measures.
- Preparation of technical documentation in accordance with FDA requirements
- Advice and support in communicating with the FDA
- Implementation of a compliance program to comply with FDA regulations
Results.
- Successful FDA approval of the product
- On-time market launch in the USA
- Improvement of internal compliance processes
Success.
The company successfully entered the US market and met the regulatory requirements.Ensure a successful market launch worldwide!
Our Global Market Access Service Portfolio.
Our portfolio supports you in fulfilling regulatory requirements safely and efficiently worldwide and successfully launching your products on international markets.
Our experts support you in complying with regulatory requirements, including MDR, FDA and Asian regulations. We take care of communication with authorities and notified bodies to ensure the conformity of your products. Further information can be found in the FDA guidelines and the MDR guidelines of the European Commission.
We develop customized strategies to successfully launch your products in different countries. Our team identifies market risks and opportunities, plans the market launch and ensures a smooth implementation. Visit our market entry strategies page to find out more
We create and maintain the technical documents required for regulatory approval in various countries. This includes the creation of approval documents, their submission to authorities and continuous updating in the event of changes to regulations. Further information can be found on our Technical Documentation page.
Reach international markets smoothly.
Global Market Access - Related topics for a successful international market launch.
These complementary services make it easier for you to access new markets and ensure compliance with local requirements:
