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Clinical Regulatory
Global regulatory solutions for your clinical study
Global regulatory support, ensuring seamless IND and CTA submissions, ongoing maintenance, and expedited study start-up timelines.
KEY FIGURES
20+
New US INDs filed per year
20+
Initial & transition CTA under the EU CTR
100+
Currently maintained INDs/CTAs globally
Secure the path for the authorization of your clinical trial
We accompany you from early training of your stakeholders, through the definition of your Clinical Trial filing strategy and planning, identification and controls of regulatory requirements, and execution of your submission and interactions with evaluating bodies.
Your global regulatory partner to achieve your operational objectives
Integrated to deliver clinical research services or partner with third-party CROs, we coordinate global trial submissions with local regulatory and in-house expertise to accelerate your applications.
Compliance and excellence as a key driver for your development
Our unwavering commitment to precision, efficiency, and quality ensures your submissions meet global standards, paving the way for streamlined approvals and accelerated development timelines.
FAQs
Can I convert my IND into the EMA’s CTR?
Not literally. The FDA’s US IND and the EU CTR support the same purpose: authorizing clinical trials with medicinal products.
Their technical format is significantly different. While the IND is published to the FDA under eCTD format, a clinical trial application (CTA) in the EU under the CTR must be processed through the online platform called Clinical Trials Information System (CTIS). This format mostly relies on data/information entered into the system’s forms, as well as a number of documents, generally in PDF format.
However, their content can be similar to some extent. For example: the study protocol, compliant with ICH standards and designed with international purpose, can be the same. Also, Quality data (Module 3) of the IND can be converted into the European Investigational Medicinal Product Dossier (IMPD).
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Does the EMA review CTA under the CTR?
No. The authorization and oversight of clinical trials is the responsibility of EU/EEA Member States while the European Medicines Agency (EMA) is responsible for maintaining CTIS. The European Commission (EC) oversees the implementation of the Clinical Trials Regulation.
The European Commission (EC) oversees the implementation of the Clinical Trials Regulation.
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Related Glossary
Clinical Trial Application (CTA)
Investigational New Drug (IND)
Common Technical Document (CTD)
Questions? Get the answers by our expert team
No two product developments are the same, talk to our experts about your development challenges and we will provide your actional recommendations.