Regulatory Submissions
We take our role in regulatory submissions seriously, centrally managing the submission process carefully and efficiently.
Globally Minded, Local at Heart
Regulatory submissions are one of the most critical milestones in a clinical research program, accelerating time to market and bringing the benefits of new treatments to patients sooner while maximizing research investments, and patent life.
Regulatory Submissions Services
Regulatory advice – developing a robust Local/Regional Regulatory strategy
Preparation of dossiers for national Competent Authorities and /or accredited Medical Ethical Research Committees (IRBs)
Submission of dossiers for national Competent Authorities and /or accredited Medical Ethical Research Committees
EU Legal representative
EU Data Controller representative
Our Services
Project Management
Flexibility, innovation, and integrity guide our approach to project management and leadership for the success of your clinical trials.
Clinical Monitoring
We provide passionate strategic knowledge, specific guidance, and expertise for study execution across multiple therapeutic areas.
Quality Assurance / 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
We manage the entire Regulatory Submission process carefully and efficiently, bringing the benefits of new treatments to patients sooner while maximizing research investments.
How is Clinical Trial Success Defined in Europe?
Bringing a product further down the development pipeline often requires conducting clinical research in Europe. However, navigating varied local regulations specific to each country, EMA, and cultural differences can be challenging. Download our RFI on to discover more about our insights, approach and experience.
Experience Matters
We offer unparalleled knowledge, support, guidance, and extremely experienced clinical research professionals to the biotechnology, life science, and medical device industries. We are committed to leading the development of new and advanced treatments.