Regulatory Services
Smooth and timelines adherent clinical trial requires deep regulatory expertise and full understanding of the regulatory process in each country where the project is planned.
Most of the deviations to the study timelines are precisely related to delays in obtaining regulatory approvals and other regulatory procedures.
Therefore, we constantly keep in sight all the regulatory aspects of each trial, and our regulatory team is involved in the preparation and conducting of the clinical trial at all stages.
The set of our regulatory services includes development of the Application file, full support in obtaining Regulatory Approvals from State regulatory bodies, LEC/IRB submission support, pharmacovigilance, and SAE reporting. Additionally, we propose full support in the registration studies and studies aiming for registration of new indications.
Break the deadlock
Favorable combination of regulatory environment and effective cost management helps revitalize promising developments
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Geographical coverage
■ ■ ■ Our geographical coverage extends to the Eastern part of the European continent. Ukraine is a key area for coordinated studies within this geographical region which, if necessary, extends to Moldova, Romania and Georgia, where we are actively developing a network of clinical sites. In addition, CLS has established strategic partnerships in the Netherlands, Poland, and Bulgaria which expands noticeably the total geographical area of our operational activities.
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