With more than 10 years of experience of eCTD and other eSubmission formats, we are a reliable and experienced partner in eSubmission services. We compile eSubmissions in accordance with all current regulations and guidelines. In case of eCTD or VNeeS, we use a current version of the appropriate validation tool to ensure a technically valid sequence is compiled and sent to the authorities using the channels designated by the authorities, such as CESP or EMA Gateway.
Our team is experienced with all eSubmission formats and has the ability to consult other medical or pharmaceutical experts, ensuring high quality eSubmission services. A second expert review is always included in our eSubmission price.
- Compilation of eCTD, VNeeS and other eSubmission type sequences
- Submission by CESP, EMA Gateway, Eudralink, secure email
- Safe way of sharing documentation and sequences between Medfiles and client by using Medfiles Extranet.
For more information please contact
Regulatory affairs Services
+358 20 744 1519 / email@example.com