Regulatory and ethics approval timelines determine when your first patient can be enrolled. For sponsors running multi-country studies under the EU Clinical Trials Regulation (EU CTR, No 536/2014), managing these timelines through CTIS is a critical path activity – not administrative support.

The EU CTR introduced a coordinated review process designed to enable faster, more consistent approvals across participating EEA member states. In practice, this requires submission teams who understand CTIS operationally, who know which documents are reviewed at which stage of the Part I/Part II process, how to write a Sponsor's Cover Letter that reduces the risk of a Request for Information (RFI), and how to manage the clock from Day 0 to the approval decision.

APICES has submitted multinational and single-country clinical trials through CTIS since the EU CTR transition became mandatory in January 2023. Our regulatory teams understand CTIS procedurally – including Part I and Part II preparation, the Assessment Report cycle, and the management of substantial modifications and end-of-trial notifications.

How APICES Manages EU CTR Submissions

• CTIS account setup and organisational registration support
• Part I dossier preparation: clinical, non-clinical, and pharmaceutical documentation in CTD format
• Part II dossier preparation: subject information sheets, informed consent forms, investigator agreements, site suitability documentation, and country-specific annexes
• CTIS submission entry and management through the complete review cycle
• RFI response preparation and submission within regulatory deadlines
• Ethics committee submission coordination in parallel with CTIS where national procedures apply
• Substantial modification submissions for protocol amendments, site additions, and IB updates
• End-of-trial notifications and lay summary submissions under Article 37

For multinational studies, APICES coordinates submissions across countries to ensure that country-specific requirements are met while maintaining consistency across the overall dossier. You have one submission team and one point of accountability – not separate local regulatory consultants in each country producing documents independently.

MDR and IVDR Clinical Investigation Submissions

For medical device sponsors, APICES submits clinical investigations under MDR Article 62 and performance studies under IVDR Article 58. EUDAMED entries for clinical investigations are managed as part of the submission workflow. Device description modules, performance evaluation plans, and clinical investigation plans (CIPs) are prepared in coordination with the medical writing and clinical strategy teams.

Special attention is given to ATMP submissions, which involve additional competent authority interactions at the national level – PEI in Germany, ANSM in France, AEMPS in Spain – alongside the CTIS process.

Paediatric, Rare Disease, and Specialised Submissions

APICES supports PIP (Paediatric Investigation Plan) submissions to the EMA Paediatric Committee, including PIP modification requests and PIP compliance checks. For orphan drugs, we manage orphan designation application support and orphan maintenance submissions including COMP annual report requirements.

For ATMPs, rare disease programmes often involve expanded compassionate use or early access programme applications alongside clinical trial submission – in particular, ATU/AAP applications in France and the hospital exemption framework in Germany. APICES coordinates these applications within the clinical trial submission timeline.

What You Can Expect

• CTIS-experienced submission team with direct EU CTR operational expertise since the 2023 transition
• Part I and Part II dossier preparation and submission management in CTIS
• RFI cycle management and Day 120/Day 150 response coordination
• Multinational submission coordination with a single point of accountability
• MDR Article 62 and IVDR clinical investigation submission support
• Paediatric, orphan, and ATMP-specific submission management
• Ethics committee coordination across Spain, France, Germany, Italy, the Netherlands, the UK, Belgium, Portugal, and Poland

Frequently Asked Questions

Do you handle EU CTR submissions through CTIS?

Yes. We have submitted multinational and single-country trials through CTIS since the EU CTR transition. We manage Part I and Part II preparation, submission, RFI cycles, substantial modifications, and end-of-trial notifications.

Do you handle MDR and IVDR submissions?

Yes. We submit clinical investigations under MDR Article 62 and clinical performance studies under IVDR, including EUDAMED entries where applicable.

Which countries do you cover?

Direct experience in Spain, France, Germany, Italy, the Netherlands, the UK (MHRA Combined Review), Belgium, Portugal, and Poland. We extend coverage as needed for specific sponsor needs.

Can you handle paediatric, ATMP, or rare-disease specifics?

Yes. We support PIP submissions to the EMA Paediatric Committee, ATMP-specific national competent authority interactions (PEI in Germany, ANSM in France, AEMPS in Spain), and orphan drug designation maintenance.

How fast can a CTIS Part I + Part II decision arrive?

Under the EU CTR, decisions on Part I + Part II typically arrive within 60 calendar days, with up to 31 additional days for RFI cycles. Country selection and protocol clarity drive whether you hit the floor or ceiling.