Regulatory Submission Support

Late-phase regulatory submissions are where the accumulated quality of your clinical programme is tested. Every inconsistency between the clinical study report and the statistical analysis plan, every gap between what was conducted and what was documented, every discrepancy between safety reporting and the study narrative – these are the issues that generate questions from EMA or FDA and extend your review timeline.

Regulatory submission support is not a standalone capability. It depends entirely on how the study was run. When the same team that designed the study, managed site activation, collected and cleaned the data, and wrote the clinical study report also coordinates the submission, the output is coherent. When submission is handed to a separate vendor at database lock, inconsistencies emerge – and then have to be resolved under timeline pressure.

APICES provides regulatory submission support as a direct continuation of clinical execution. The teams involved in preparing submission materials are the same teams who conducted the study. That continuity is the mechanism that produces submission packages regulators can review without requesting extensive clarification.

What Regulatory Submission Support Covers

• Preparation and review of clinical study reports (CSRs) for EMA, FDA, MHRA, and national competent authority submissions
• Coordination of Module 5 (Clinical Study Reports) and Module 2.7 (Clinical Summary) content for MAA/NDA/BLA submissions
• Management of submission timelines, document versions, and cross-functional review cycles
• Authority interaction support: response preparation and document amendment following Day 120 List of Questions responses
• Close-out documentation: study completion reports, end-of-study notifications under EU CTR, and post-study follow-up reporting
• Integration of safety reporting (DSURs, PSURs, aggregate safety reports) into the broader submission timeline

Submission support under the Clinical Trials Regulation (EU) No 536/2014 is handled through CTIS, including substantial modification submissions and end-of-trial notifications.

Authority Experience and Regulatory Frameworks

APICES has hands-on experience with submissions to EMA, FDA, MHRA, AEMPS (Spain), ANSM (France), BfArM (Germany), AIFA (Italy), and the Netherlands CBG-MEB. Regulatory writers and submission coordinators are familiar with the specific procedural expectations of each authority – not just the common technical document structure.

For sponsors with global development programs, submission activities can be coordinated across EU and US timelines, ensuring that CSR content and the Statistical Analysis Plan are consistent across jurisdictions. This is particularly relevant for oncology biologics and rare disease programs where EMA and FDA interactions often run in parallel.

Authority interaction management is included as standard. When an EMA Day 120 List of Questions or an FDA Complete Response Letter generates a requirement for additional data or clarification, APICES coordinates the clinical, statistical, and medical writing response as a connected activity.

Submission Readiness Built into Study Conduct

The most effective way to reduce submission risk is to design submission readiness into the study from the start. At APICES, regulatory submission requirements inform study design decisions: endpoint definitions, statistical analysis plan structure, data collection standards, and reporting timelines are set up so that the CSR and submission documentation can be prepared efficiently once the study is complete.

Sponsors who engage APICES for submission support after an externally conducted study encounter a different level of complexity. Document reconstruction, inconsistency resolution, and retrospective quality reviews add time and cost. When submission support is part of the integrated service, none of those steps are necessary.

What You Can Expect

• Coordinated submission package preparation aligned with EMA or FDA procedural requirements
• CSR and clinical summary documentation prepared by the same team that conducted the study
• Managed authority interaction cycles with structured response preparation
• Cross-functional alignment across biostatistics, medical writing, safety, and clinical operations
• Submission timelines integrated into the overall clinical operations plan
• Experience with CTIS, eSubmission Gateway, and FDA eCTD submission formats

Frequently Asked Questions

Which authorities can APICES submit to?

EMA (including CTIS/EU CTR), FDA (IND and NDA/BLA modules), MHRA (post-Brexit combined review pathway), AEMPS (Spain), ANSM (France), BfArM (Germany), AIFA (Italy), and CBG-MEB (Netherlands). We also support PMDA engagement for global programs.

Can APICES support both EMA and FDA submissions simultaneously?

Yes. For global development programs, we coordinate EU and US timelines to ensure CSR content, SAP interpretation, and narrative consistency are aligned across jurisdictions before submission.

What does APICES include in a Day 120 response package?

Clinical, statistical, and medical writing coordination to address each question; revised document sections; and a consolidated response document prepared to EMA procedural standards.

Do you handle end-of-trial notifications under EU CTR?

Yes. End-of-trial notifications, substantial modifications, and lay summary submissions (Article 37) are managed through CTIS as standard components of the regulatory lifecycle.

How does submission support connect to the rest of the study?

Because APICES conducts the study and prepares the submission, there is no handover. The team that designed the statistical analysis plan is the team that interprets the results. That continuity is what makes submissions coherent.