eCTD Submissions

Sarjen helps its clients accelerate innovation and increase their ROI considerably in R&D and provide quick and intuitive construction of complex electronic submission for any regulatory authority. It provides a simple and a easy-to-use user interface with multiple regional support that includes Canada, EU and US with multiple parallel users.

Sarjen is one of the very few software vendors vantaged with intellectual and effective strategic corporate level consulting and has considerable number of successful submission of eCTDs and eDMFs to its credit. Geared up with an integrated validator, which provides accuracy, efficiency and robustness to the cumbersome submission process. The constant consultancy that Sarjen provides makes your submissions furthermore easy.

US FDA Submissions

ANDA Submission

Sarjen offers the following regulatory operation services to ensure US FDA acceptable eCTD enabled ANDA submissions:

• Submission map creation in CTD format
• Granularity and life cycle management of documents
• US FDA specific document formatting and publishing
• Navigation Aid Management including the table of contents and hyperlinks
• Dossier assembly and compilation in eCTD format
• Paper to Electronic document conversion to provided searchable text based documents as required by US FDA
• Electronic Submissions gateway setup and administration

For small sized generic companies, we provide Pay per Dossier conversion to create eCTD based ANDA submissions.

European Medicines Agency (EMEA)

The recent mandate from EMEA is that no paper submission should be submitted to any regulatory agency within the EU after January 1, 2010 for the centralized procedure that includes EMEA, Rapporteurs and all CHMP members.

Sarjen's consulting team carries extensive experience in providing consulting for any eSubmission made in the context of a Centralized/Decentralized/National/Mutual Recognition application procedure and the subsequent maintenance of the life cycle of the application including:

• Initial application
• Supplementary information
• Variations
• Renewals
• Follow up measures (FUMs)
• Periodic Safety Update Reports (PSURS)
• Notifications
• For small sized generic companies, we provide Pay per Dossier conversion to create eCTD based submissions