The Accelsiors Regulatory team has the 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 with a whole project team;
- compliance with both, international and local regulatory requirements thanks to experienced regional and local regulatory representatives;
- quality of deliverables that we pay a special attention to when working under pressure, within strict deadlines.
- Regulatory strategy development;
- IMPD development / review;
- Label text development / review;
- Procurement of clinical trial liability insurance;
- Providing 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
- Regulatory Management of entire lifecycle of a clinical trial including international and local regulatory requirements compliance.