A close collaboration of scientific writers and biostatisticians to design your research project and communicate…
To help you successfully navigate regulatory hurdles.
Always up to date on the latest regulations in force, we will help you navigate the regulatory landscape, identify the hurdles and define the appropriate strategy to follow.
UNDERSTANDING THE GLOBAL REGULATORY LANDSCAPE IS CRITICAL
TO THE SUCCESS OF YOUR CLINICAL PROGRAMME
Our team in charge of regulatory affairs and submissions to authorities, is composed of experienced experts, who can guide you through the intricate area of regulatory issues and approval timeframes. They will also provide you with all the options to help you choose the best strategy
OUR MOTTO: A CONSTANT REGULATORY WATCH
We bring you insight on the latest regulations governing drugs, biological products, gene/cell therapies or medical devices at any stage of their clinical development. Combined with our operational expertise, we ensure that your clinical trial is aligned with the latest regulatory agency requirements.
OUR SERVICES INCLUDE
Regulatory strategy support and guidance to optimise your project start-up
Consulting and advice on national legislations and specific requirements
Medical writing support (Protocol, PUT-RD, Informed Consent Form, Case Report Form, etc…)
Core study documents translation and adaptation to local regulatory requirements
Compilation of clinical study authorisation application dossier and submission according to local/ European regulations
Compliance with GDPR and assessment of data privacy compliance
Responses to requests for information from regulatory bodies
Management of site contracts
Regulatory submission of SUSARs and DSURs
Electronic submission to EudraVigilance
Expedited reporting to the national Competent Authorities and Ethics Committees according to European regulations
With local partners who keep on top of the changing regulatory environment across Europe, we provide crucial links to major regulatory authorities and are skilled in the preparation, coordination, and management of complex multinational submissions.
Please note that the new European regulation EU 536/2014 EU53/2014 on clinical trials on medicinal products for human use in Europe is now applicable to all projects that have started and that will end after 31 January 2025. Our teams in charge of regulatory submissions have all been trained to this new regulation.