Verify if your hyperlinks are working and publish incrementally to check your progress. Navigation with autocompile function, easily accessible from anywhere. Use the integrated eValidator just like the health authorities use.
PhlexSubmission 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 our automated eCTD software solution, 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 formats 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, GCC, JO
Designed for all submission types such as variations, renewals, PSURs, ASMFs, DMFs
Smooth transition from paper to electronic submission
Integrated validator used by most health authorities
Made to submit marketing authorisation applications (MAAs and NDs and BLAs)
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 seamlessly integrated document management module area –> 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 that makes all your documents submission ready
Step 3: You add the metadata for the product (Substances, Substance Manufacturer, Product Manufacturer, Excipients, Indications, Studies if applicable)
Step 4: You create a new submission and submission software PhlexSubmission automatically creates the correct eCTD format and initial sequence number
Step 5: You compile the eCTD sequence for this submission, publish and submit it to the health authority