We provide expert guidance on regulatory requirements for clinical trials, from start-up to final report submission and beyond!
We manage the complete submission process to regulatory authorities and ethics committees, ensuring smooth and timely trial approvals!
We provide continuous regulatory support throughout the trial to ensure post-approval compliance!
We provide expert guidance on regulatory requirements for clinical trials, from start-up to final report submission and beyond!
We manage the complete submission process to regulatory authorities and ethics committees, ensuring smooth and timely trial approvals!
We provide continuous regulatory support throughout the trial to ensure post-approval compliance!
Our Regulatory Affairs Managers manage over 200 yearly submissions covering all study types and phases!
Our team manages submissions in over 30 European countries from our head office, and together with AICROS and local partners, supports regulatory activities in more than 50 countries globally.
With zero rejections, our regulatory submissions consistently lead to trial approvals and favorable ethics committee outcomes!
The regulatory start-up process is a critical initial phase in any clinical trial. Our Regulatory Affairs Team manages all necessary submissions to Competent Authorities (CAs) and Ethics Committees (ECs), with a strong emphasis on minimizing potential queries. This proactive approach ensures a smooth and timely trial initiation.
We provide expert guidance on regulatory requirements throughout the entire lifecycle of a clinical trial, from initial planning and start-up to final report submission and post-trial obligations. Our team supports you in identifying all necessary approvals and authorizations, selecting the appropriate submission pathways, and ensuring compliance with local and international regulations. With our proactive approach, we help streamline the regulatory process and mitigate potential delays.
We manage the entire submission process to regulatory authorities and ethics committees, ensuring smooth and timely trial approvals. Our team provides comprehensive guidance in collecting and preparing all required documentation, tailored to the specific study type, whether it involves a medicinal product, a medical device, or another clinical research category. We handle submissions through the appropriate regulatory pathway and maintain close communication with authorities to promptly address any queries. Our efficient response management, even within tight deadlines, helps minimize delays and supports a timely initiation of your clinical trial.
We provide continuous regulatory support throughout the entire duration of your clinical trial to ensure full post-approval compliance. Our team maintains oversight of all required notifications, amendments, and updates to submitted study documentation, ensuring that regulatory obligations are consistently met. We remain actively available to address any regulatory questions or issues that may arise during the conduct of the trial, helping you navigate ongoing requirements with confidence and efficiency.
