Verify if your hyperlinks are working and publish incrementally to check your progress. Use the swift navigation with autocompile function, easily accessible from anywhere. The environment is hosted, managed and validated.
PhlexSubmission eCTD includes a sophisticated hyperlink manager which ensures your PDF links are accurate and in place. No more worrying about broken links when you finalize your submission.
With the most automated eCTD solution available, you will be ready to manage all of your submissions globally, migrate from paper to electronic submissions (eSubmissions), and be guided by our built-in virtual trainer to help you through each step of the process.
Open and view eCTD, NeeS and other dossier fromats from anywhere. Of course, you can invite internal and external team members and share your dossier.
We Are Driven By Our Desire To Be A Reliable Partner To Our Customers
Guaranteed ICH Compliance – no maintenance needed
Compile eCTD’s for US, CAN, EU, CH, SA, TH, JP, AUS, SAUD
Designed for all submission typs such as variations, renewals, PSURs, ASMFs
Smooth transition from paper to electronic submission
Automated NeeS to eCTD conversion
Made to submit marketing authorisation applications (MAAs)
Regulatory eCTD Training included
Use Phlexglobal expertise and automation workflows to transform existing submissions (e.g. NeeS or CTD) to eCTD
Step 1: You simply take your NeeS folder and create a ZIP file of your entire NeeS folder structure
Step 2: You upload that ZIP file to the Cunesoft RDMS module–> The system will then automatically create a product, create the folder structure from your NeeS and add all documents into the folders. Finally, a one click bulk publish then makes all your documents publishing ready.
Step 3: You add the meta data for the product (Substances, Substance Manufacturer, Product Manufacturer, Excipients, Indications, Studies if applicable)
Step 4: You create a new submission and submission software cune-eCTD automatically creates the correct eCTD for your NeeS as Sequence 0000
Step 5: You compile the eCTD sequence for this submission, publish and submit it via the CESP