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.
Choose the procedure
The centralised procedure gives a single authorisation valid across all EU and EEA countries, mandatory for certain product types and optional for others. National, mutual-recognition, and decentralised procedures cover the remaining cases.
Authorise the trial through CTIS
The Clinical Trials Regulation (EU) No 536/2014 governs trials end to end. Applications run through the Clinical Trials Information System, mandatory for new trials since January 2023 and for all ongoing trials since January 2025, assessed in a coordinated Part I led by a Reporting Member State and a national Part II.
Register to operate in the system
Sponsors need an EMA account and organization registration through OMS and SPOR, with suspected unexpected serious adverse reactions reported through EudraVigilance.
Respond and conclude
Assessment brings requests for information and questions from EMA and member states. Once the scientific assessment concludes positively, the European Commission grants the marketing authorisation.
Devices and diagnostics too: we prepare Clinical Evaluation Reports and IVDR performance evaluation documentation for Notified Body review, an area of genuine delivered experience for us.
What we prepare
MAA dossiersCentralised marketing authorisation applications in CTD and eCTD format.
EU Module 1 and summariesRegional content, clinical overviews, and clinical summaries.
CTIS applicationsClinical trial applications, including Part I and Part II documentation.
Regulatory strategyProcedure selection and scientific advice briefing documents.
RFI responsesResponses to requests for information and assessment questions.
Device documentationClinical 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
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.
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.
Yes. We prepare Clinical Evaluation Reports and IVDR performance evaluation documentation for Notified Body review, an area of genuine delivered experience for us.
Have a different question?
Tell us about your product, market, and timeline, and a clinician on our team will reply with specifics rather than a sales script.
Request a proposalRegulatory submissions in other markets
Entering the EU market?
Tell us about your product and timeline, and we will come back with a scoped proposal for the dossier and strategy work.
Request a proposal