Regulatory Affairs

A comprehensive solution to navigate all clinical regulatory needs around the world

Our Global Regulatory Unit will help you to navigate through the maze of complex legal landscape of drug development and we provide useful guidance to handle in time the different expectations of the European (EMA), US (FDA), and many other regulatory agencies around the world.

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Regulatory Affairs

Accelsiors’ Regulatory team has the right experience and know how to support our Clients over the entire lifecycle of a clinical trial and ensure that all of their regulatory goals are achieved within the required timelines.

The Regulatory team’s mission is to guide Customers through the regulatory aspects of the study and devise the best strategy for meeting corporate objectives. Additionally, we pride ourselves on our ability to define and support the most efficient pathway for the development process and marketing applications.

WE ARE CONSCIOUS OF THE IMPORTANCE OF

regulatory timelines that we set and achieve, thanks to close collaboration within a whole project team
compliance with both, international and local regulatory requirements, thanks to our experienced regional and local regulatory representatives
quality of deliverables that we pay a special attention to when working under pressure, within strict deadlines

Feel free to ask Accelsiors’ Clinical Development experts!

Let’s start discussing about how we can support your pipeline! Please, contact us:

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Call Us: +36 1 299 0091
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and we will schedule a meeting around your calendar!

REGULATORY SERVICES

Regulatory Management of entire lifecycle of a clinical trial including compliance with all international and local regulatory requirements, such as Regulatory strategy development
IMPD development / review
Label text development / review
Procurement of clinical trial liability insurance

Legal representative services for non-EU customers
Collection and review of regulatory documents
Compilation of dossiers for CTAs to ECs and CAs
Management of submission processes
Investigational Product (IP) Release – IPR form

Learn more about our comprehensive clinical development services

Accelsiors offers a complete range of expertise in support of your specific needs: Scientific, analytical and regulatory complemented by global resources, state-of-the-art technologies and project management methodology for the most effective execution of your development program across all phases of clinical drug development.