Pharmaxi offers comprehensive CTIS submission support for clinical trials conducted under the EU Clinical Trials Regulation (EU CTR 536/2014). Our team manages every step — from organization registration to final study results submission — ensuring your documentation meets all European and local regulatory standards.
What’s included in our CTIS Submission Service
Registration of sponsors, vendors, and sites in the Organization Management System (OMS)
Setup of sponsor accounts and user roles within CTIS
Preparation and validation of Part I and Part II documentation
Regulatory review of ICFs and IMP labels according to country-specific requirements
Formatting and compliance check of the full submission package
IMP and Substance registration in XEVMPD
Uploading and ongoing management of documents within CTIS
Communication with Competent Authorities and Ethics Committees
Handling of substantial modifications and notifications
Post-submission support, including Summary of Results, Lay Summary, and CSR submission
Medical writing support for key documents, including CSPs, CSP reductions, ICFs, layperson synopses, and summaries of results
How Pharmaxi manages CTIS submissions
With direct experience working in CTIS since its launch, we ensure efficient validation, consistent document structure, and alignment between Part I and Part II submissions. Our regulatory experts provide continuous support — from initial submission through post-approval updates — guaranteeing smooth communication with authorities and timely responses to RFIs.
If you’re ready to submit your CTA under the EU CTR, contact Pharmaxi for expert regulatory guidance – 30 min consultation. We handle every aspect of the submission process — so you can focus on the science, while we take care of compliance.
