EU CTR Submissions

Simplify your EU CTR submission imperatives with our tailored EU CTR submissions approach guided by our expert team. Our expert team ensures compliance from CTA management to data transparency until CTIS submissions. Focus on innovation while we manage your EU CTR needs.

EU CTR Submissions - Overview

On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU until the Regulation entered into application. Under this new regulation, clinical trial sponsors must submit all new clinical trial applications (CTAs) in the Clinical Trials Information System (CTIS) from 31 January 2023. National EU Member States and EU/EEA regulators also use CTIS.

Additionally, the following pointers highlight some of the key timelines for EU CTR adoption and readiness for its relevant stakeholders.

  • All ongoing clinical trials in the EU must be transitioned to the CTIS by 30 January 2025.
  • The revised CTIS transparency rules become applicable on 18 June 2024. Detailed information is available at EMA Webpage Guidance and Q&As - EMA (
  • With these new regulations, Sponsors must consider the time necessary to complete the Member State procedure, which can take up to 3 months. Therefore, EMA advises sponsors to submit the applications well in advance of the end of the transition period on 30 January 2025.

These timelines underline the importance of having a who can swiftly manage and abide the dates and uphold submissions compliance.


Our services are designed to cater end-to-end services for Clinical Trial Information Systems (CTIS). Our services include the following:

  • Design of Interventional Clinical Study Protocol, which is required to follow European Union (EU) Clinical Trial Regulation (CTR) No 536/2014
  • Centralization of clinical trials via CTIS, which requires support right from the Clinical Trial Application (CTA) to the submission of the Clinical Study Report (CSR)
  • Data Transparency Services from the start of the trial registration to the marketing application phase
  • Support for developing SOPs and guidelines specific to CTIS on a need basis
  • EU-CTR/ CTIS Quality assurance

Expert Team

Freyr's EU CTR Regulatory Team has extensive knowledge of emerging regulations and processes for EU CTR implementation and submission.

Our team of thirty (30) EU CTR Regulatory experts including managers and associates with proficient experience in clinical trials supports our stakeholders, and sponsors for EU CTR implementation.

EU CTR Submissions

  • Develops the operational implementation plan for CTAs in all regions from initial submission throughout the lifecycle, in alignment with the global submission strategy. This may concern trials across a variety of Therapeutic Areas, including oncology, gastrointestinal and inflammation, marketed products, and neuroscience.
  • Executes or oversees all activities related to the creation, submission, and maintenance of CTAs Globally and in Europe through the EU CTIS or legacy processes in conformity with legal requirements.
  • Ensures oversight and tracking of CTA activities and electronic Trial Master File (eTMF) updates in collaboration with other teams to achieve compliance.

Freyr understands the requirements of the sponsors for EU CTR and provides customized solutions and support to meet the submission timelines. Freyr has a well-defined strategy to approach the EU-CTR submissions.

  • Initial Consultation - We understand your requirements, assess your current processes, and identify gaps with respect to compliance with the new regulations of EU CTR.
  • Strategic Planning - We develop a tailor-made plan suitable to meet your requirements and aid in providing a seamless transition per EU CTR requirements.
  • Execution and Support - We could support you with end-to-end activities including preparation of protocol and Informed Consent Form per EU CTR submission requirements, actual submissions, preparation and submission of CSRs, submission of safety data from ongoing clinical studies
  • Continuous Support - We help you to navigate the complexities of EU CTR, which would minimize the risk of non-compliance and ensure smooth operations.
  • Optimized Resources - By letting us handle your EU CTR submissions, your resources could focus on your key business aspects of Innovation and Drug Development.

Why choose us as your EU CTR Submission guide?

The dedicated CTIS Expert team has in-depth knowledge of the CTIS platform and European regulations that help to provide cost-effective solutions to sponsors ensuring timely submissions.

“Your input matters to us”

Going ahead we plan to host EU CTR submissions-based webinars.

Let us know what topics under EU CTR arena interest you most. Let us know and influence our webinar content by clicking here.

Celebrating Customers Success


Medicinal Products

Regulatory Affairs


Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company


Medicinal Products



I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company


Medicinal Products

Regulatory Affairs


Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant


Medicinal Products

Regulatory Affairs


Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​


Medicinal Products

Regulatory Affairs


Thank you all for the great support!​


US-based, Leading Innovative Pharmaceuticals Company​


Medicinal Products

Regulatory Affairs


The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​