Electronic Submission Support

(Common European Submission Portal): A mandated platform for the submission of (eCTD/NeeS/vNeeS) dossiers for Marketing Authorization Applications (MRP, DCP, or NP) and Active Substance Master Files (ASMFs) across most European countries.

Serving as a central electronic submission platform for various regulatory applications related to medicinal products in the European Union, covering Marketing Authorization Applications (MAAs), Clinical Trial Applications (CTAs), and Post-Authorization Applications.

A secure online platform provided by the European Medicines Agency (EMA) for secure file transfer among stakeholders including the EMA, National Competent Authorities, Pharmaceutical Companies, and experts.

If you do not have appropriate knowledge for finding this balance, calling in assistance from an experienced regulatory consultant like STARoDub B.V. can avoid unnecessary delays and speed up the regulatory approval.

(Electronic Submissions Gateway): A secure portal for submitting regulatory information to the U.S. Food and Drug Administration (FDA), accommodating various electronic submission formats such as eCTD, SPL, PDF, and XML for FDA-regulated products.

Discover more about our eCTD services.

An online platform facilitating the exchange of regulatory and scientific information between the EMA and organizations developing medicinal research products for potential use in the European Union, covering procedures such as orphan designation, parallel distribution, scientific advice, and inspections.

• document numbers and versions, 
• location in the document management system, 
• status of documents (e.g. draft/approved),
• expected delivery dates,
• publishing status.

The national portal of the Medicines and Healthcare products Regulatory Agency (MHRA) facilitating electronic submissions for regulatory activities in the UK healthcare sector, including Medicines Marketing Authorizations, Medical Device Registrations, Clinical Trial Applications, and Pharmacovigilance Reporting.

• document numbers and versions, 
• location in the document management system, 
• status of documents (e.g. draft/approved),
• expected delivery dates,
• publishing status.

as most applications are submitted via national or regional submission portals, a so-called XML file will need to be generated. These XML files are required for electronic submissions and contain structured data formatted according to predefined standards.