By partnering with ICTA, you are joining forces with a dedicated team of scientific writers…
Regulatory affairs
Regulatory hurdles don’t have to slow you down.
Our expert team stays continuously updated on the latest regulations and guidelines, helping you anticipate challenges, overcome obstacles, and chart a clear, compliant path forward. From early planning to execution, we work with you to develop a smart, customized regulatory strategy that keeps your clinical development on track and aligned with global standards.
Making sure you move fast.
UNDERSTANDING THE GLOBAL REGULATORY LANDSCAPE IS CRITICAL TO THE SUCCESS OF YOUR CLINICAL PROGRAM. DON’T LET IT HINDER YOU!
Our regulatory affairs and submissions team is composed of experienced experts who can guide you through the complexities of regulatory issues and approval timeframes. They will also present all the available options to help you select the most suitable strategy. Save precious time, avoid complications.
OUR MOTTO: A CONSTANT REGULATORY WATCH
Gain a competitive edge with our in-depth knowledge of the latest regulations affecting drugs, biologics, gene and cell therapies, and medical devices—across every phase of clinical development. By combining cutting-edge regulatory intelligence with proven operational expertise, we help ensure your clinical trials meet the evolving requirements of global regulatory agencies—streamlining approval and accelerating time to market.
WE PROVIDE YOU WITH THE FOLLOWING SERVICES :
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 and submission of a clinical study authorisation application dossier according to local and/or 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 the support of our trusted local partners who stay on top of Europe’s constantly evolving regulatory landscape, we offer direct and timely access to key regulatory authorities across the region. Our experienced team specializes in preparing, coordinating, and managing complex multinational regulatory submissions—ensuring your clinical development stays on track and compliant from start to finish.
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.
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