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

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.

Get in Touch

We offer unparalleled knowledge, support, guidance, and extremely experienced clinical research professionals to the biotechnology, life science, and medical device industries.

Get in touch to learn more about how we can help navigate complex clinical trials in Europe or download our RFI pack.