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)

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.
customized fsp 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.

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