Unlimited Submissions
Unbeatable when doing multiple submissions per year
Unlimited Countries
Submit your INDs, variations, annual reports, MAs or DMFs worldwide
Outstanding Support
We promise you a 100% eCTD compliance guarantee
Fully
Validated
Always be prepared for an FDA audit
20/5 support availability
Regulatory support
We understand your needs and created an environment with outstanding and unique regulatory support – we will give you live training via Internet, we will always answer to your inquiry. Just call or write our support as often as needed! And most important – we help you not only with technical questions, but 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. Use the swift navigation with autocompile function, easily accessible from anywhere. The environment is hosted, managed and validated.
Manage Hyperlinks
PhlexSubmission, electronic submission software, 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, 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 Phlexglobal DMS 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 PhlexSubmission automatically creates the correct eCTD format for your NeeS as Sequence 0000
Step 5: You compile the eCTD sequence for this submission, publish and submit it via the CESP
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
Phlexglobal provides a unique Trial Master File solution by leveraging dedicated and authoritative TMF technologies and expert services to bring order, stability, and control to your Trial Master File – helping you achieve the highest standards for completeness, timeliness, and quality.
UK: +44 (0) 1494 720420
US: +1 (484) 324-7921
E-Mail: info@phlexglobal.com