ELECTRONIC DOSSIER
For the electronic dossier section - Optimize the process of drug registration with a professionally prepared electronic dossier!

Our team of specialists will help you collect, systematize and prepare all the necessary documents in accordance with the requirements of the Ministry of Health of the Russian Federation, Roszdravnadzor, the EAEU, ICH, FDA, EMA and other regulatory bodies.

Why is an electronic dossier convenient and effective?
Full compliance with international standards (CTD, eCTD, ACTD)

Fast submission via electronic systems
Automated error checking before submission
Convenient storage and access to documents 24/7
Reduced risk of refusal due to strict quality control

Our services include:
Preparation of a full package of documents for drug registration
Conversion of documents into electronic xml format
Structuring by CTD sections (Modules 1-5)
Checking for compliance with regulatory requirements
Technical support for submission and responses to requests

Timeframes and cost depend on the type of registration (new, re-registration, generic) and the volume of data.

Leave a request for a consultation, and we will help you register without unnecessary delays!

Your drug – our expertise!