Unlimited Submissions
Unbeatable when doing multiple submissions per year
Global Coverage
Submit your INDs, variations, annual reports, NDAs, MAs, ASMFs and DMFs worldwide
Outstanding Expert Support
We promise you a 100% eCTD compliance guarantee
Fully
Validated to Support Your Compliance
Always be prepared for an FDA audit
20x5 support availability
Regulatory support
We understand your needs and have created an environment with outstanding and unique regulatory support – we will give you live training via Internet, we will always answer your inquiry. And most importantly – we help you with both technical questions and with the overall processes in addition to how to use PhlexSubmission. With our eCTD submission software we guarantee your eCTD compliance.
Check Compliance
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.
Manage Hyperlinks
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.
All Regions
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.
eCTD Viewer
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
Join our community of over 500 Active Users
Regulatory Affairs Manager, Germiphene
Head of Regulatory, Makrocare
Regulatory Specialist, Athenex
Be 100% eCTD Compliant
Use the Phlexglobal guarantee for your first submission
Training on using the ESG (Electronic Submission Gateway):
Speedy start-up, training and validation
Work With the Right Tool
Use built in submission templates based on latest FDA/ICH requirements
Assistance in setting up your FDA Account
Rely on Phlexglobal experience to work more efficiently
Save Money
Make use of the cost control via an annual all inclusive subscription fee
Get the job done
GxP aligned and fully validated
Never Be Alone
Ongoing eCTD support via a 1 hour guaranteed response time
Work Confidently
No system installation needed – we maintain a validated environment for you
Use State-of-the-art Software
21CFR11 compliance via private SaaS (Software as a Service)
Depend on Phlexglobal's experience:
Support to prepare the required eCTD test submission
See for yourself - watch our video demonstration
UK: +44 (0) 1494 720420
US: +1 (484) 324-7921
Poland: +48 81 45 46 132
Germany: +49 89 23514741
E-Mail: info@phlexglobal.com