Regulatory Submissions
We take our role in regulatory submissions seriously, centrally managing the submission process carefully and efficiently.
Globally Minded, Local at Heart: Regulatory Submission in Clinical Trials
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 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 (IRBs)
Submission of dossiers for national Competent Authorities and /or accredited Medical Ethical Research Committees
EU Legal representative
EU Data Controller representative
Pharmacovigilance: assisting and ensuring appropriate reporting of CIOMS, DSURs, annual IDB updates
Our Services
Customizable FSP
Our Expertise, On Your Terms
Customizable Functional Service Provider (FSP)
Project Management
A Seamless Extension of Your Organization
Project Management
Clinical Monitoring
Expert Support for Your Investigators and Teams
Clinical Monitoring
Quality Assurance and Control
Accuracy and Integrity
Quality Assurance and Control
Regulatory Submissions
Globally Minded, Local at Heart
Regulatory Submissions
Additional Services
Partnerships at the Core of Medicine
Additional Services
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.
Experience Matters
As an international contract research organization (CRO), we offer unparalleled knowledge, support, guidance, and 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 by offering a range of CRO clinical trial services, from Customizable FSP to full-service.