EMA Submission Support for the EU
The European Medicines Agency (EMA) coordinates scientific assessment across the EU, with the European Commission granting the marketing authorisation. EvySaif provides EMA submission support, preparing the dossiers and regulatory strategy for the EU’s procedures, whether you are pursuing a centralised marketing authorisation or authorising a clinical trial through the modern EU system.
- Understanding the EU pathways
A marketing authorisation can be sought through the centralised procedure, which yields a single authorisation valid across the EU and EEA, or through national, mutual-recognition, and decentralised procedures for other cases. All are built on the CTD and eCTD structure with an EU-specific Module 1. For clinical trials, the Clinical Trials Regulation (EU) No 536/2014 now governs the process end to end, and applications run through the Clinical Trials Information System (CTIS), the single EU portal that became mandatory for new trials in January 2023 and for all ongoing trials in January 2025, replacing the old Clinical Trials Directive. A CTIS application is assessed in two parts, a coordinated scientific Part I led by a Reporting Member State and a national Part II, with suspected unexpected serious adverse reactions reported through EudraVigilance. Sponsors need an EMA account and organization registration through OMS and SPOR to operate in the system.
- What we prepare
- Centralised marketing authorisation application (MAA) dossiers in CTD and eCTD format
- EU Module 1 regional content, clinical overviews, and summaries
- CTIS clinical trial applications, including Part I and Part II documentation
- Regulatory strategy: procedure selection and scientific advice briefing documents
- Responses to requests for information (RFIs) and assessment questions
- For devices, Clinical Evaluation Reports and IVDR performance documentation for Notified Body review
- How EvySaif helps
We are your scientific writing and strategy partner for the EU. We author the MAA or CTIS dossier, advise on the right procedure, and prepare your responses to EMA and member-state questions. We work alongside your EU-based representation where the framework requires it, so your submission is both well built and correctly placed in the system.
- Why EvySaif
EvySaif ranks among the best research and medical writing consultancies in India, and our device and diagnostics experience gives the EU work particular strength, since the IVDR and MDR are where much of our delivered documentation sits. For drug submissions, our clinician-led writing meets the standard EMA and member states expect.
- Frequently asked questions
What is the centralised procedure?
A single application to EMA that, once approved by the European Commission, gives one marketing authorisation valid across all EU and EEA countries. It is mandatory for certain product types and optional for others.
Do all EU clinical trials go through CTIS now?
Yes. Since January 2023 all new trial applications must use CTIS, and since January 2025 all ongoing trials must comply with Regulation 536/2014 and be recorded in CTIS.
Can you support medical device submissions too?
Yes. We prepare Clinical Evaluation Reports and IVDR performance evaluation documentation for Notified Body review, an area of genuine delivered experience for us.