[test]
Regulatory Submission Services
Regulatory advice – developing a robust Local/Regional Regulatory strategy
Preparation of dossiers for national Competent Authorities and /or accredited Medical Ethical Research Committees
Submission of dossiers for national Competent Authorities and /or accredited Medical Ethical Research Committees
EU Legal representative
EU Data Controller representative
Our Services
Customizable FSP
Our Expertise, On Your Terms
Customizable Functional Service Provider (FSP)
With our Customizable FSP model, we provide specialist expertise and fulfill specific tasks and functions you need at every stage of your clinical trial.
Project Management
A Seamless Extension of Your Organization
Project Management
Flexibility, innovation, and integrity guide our approach to project management and leadership for the success of your clinical trials.
Clinical Monitoring
Expert Support for Your Investigators and Teams
Clinical Monitoring
We povide passionate strategic knowledge, specific guidance, and expertise for study execution across multiple therapeutic areas.
Quality Assurance and Control
Accuracy and Integrity
Quality Assurance and Control
We pride ourselves on accuracy and integrity through a continual and dynamic process when it comes to quality assurance and quality control.
Regulatory Submissions
Globally Minded, Local at Heart
Regulatory Submissions
We take our role in regulatory submissions seriously, centrally managing the submission process carefully and efficiently.
Additional Services
Partnerships at the Core of Medicine
Additional Services
We are focused on sharing our expertise and building industry partnerships, for international and regional clinical research.
How is Clinical Trial Success Defined in Europe?
Bringing a product further down the development pipeline often requires conducting clinical research in Europe. In the EU, the Clinical Trials Regulation harmonizes the submission process, but local requirements are still varied and specific to each country, and cultural differences can be challenging.
What defines clinical trial success in Europe? Download our RFI on to discover more about our insights, approach and experience.
learn more
Discover more about our brand and vision for a brighter tomorrow.
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud.