What US companies should know
Entering the European Union with clinical trials
Entering the European Union with a clinical trial brings a unique set of regulatory, operational, and cultural complexities. As we are an European company who knows US biopharma, our understanding on the EU environment and our services such as legal representation and regulatory submissions help you succeed.
Book now a free of charge, non-binding consultation session for a look into your roadmap to the European market.
Free consultation: How to enter the EU market with a clinical trial?
How we can help you:
EU legal representation
Non-EU-based sponsors need a European company as their legal representative. We offer a contract with Non-EU Sponsors to provide the required legal representative, including the responsibilities of the sponsor with regards to GCP and regulatory compliance.
Regulatory services in the EU
We support your preparation and conduct of clinical trial.
- Regulatory strategy and development planning
- Preparation of applications, documents and translations
- Competent Authority and Ethic Committee submissions and communication
- Regulatory/GCP Compliance
Navigating European regulations
Our services help US companies navigate through the European regulatory environment and enter the market. We support you with for example
- Clinical Trials Regulation (EU) No 536/2014
- GDPR (General Data Protection Regulation)
- National regulations
Data management and GDPR
We have a dedicated inhouse team of experts ready to help you with data management and data privacy questions.