PhlexSubmission

Electronic Common Technical Document (eCTD) Sofware

Create new or import existing electronic submissions with ease.

Compliant. Fast. Successful.

PhlexSubmission is a robust, highly configurable and easy-to-use publishing engine for electronic submissions such as eCTD, NeeS, VNeeS but also it can provide paper publishing capabilities for CTD and any custom type submissions that might be required.

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Unique eCTD Submission Software Benefits

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Unlimited Submissions

Unbeatable when doing multiple submissions per year
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Unlimited Countries

Submit your INDs, variations, annual reports, MAs or DMFs worldwide
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Outstanding Support

We promise you a 100% eCTD compliance guarantee
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Fully
Validated

Always be prepared for an FDA audit

 

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Expert Services: Our Secret To Your Success

 

Over 70% Of Our Support Calls Are NOT Related To The Technology Itself...they are almost always questions about where to start.

  • 20/5 support availability
  • 1 hour response time
  • Technical support services

  • Regulatory support 
  • Adhoc user training
  • eCTD Compliance Guarantee

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 cune-eCTD. With our eCTD submission software we guarantee your eCTD compliance.

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Like Nothing You've Seen Before

 

eCTD Submission Software Quick Tour

 

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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.
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Manage Hyperlinks

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.
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All Regions

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.
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eCTD Viewer

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.

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We Deliver Regulatory Peace Of Mind

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

Peace of Mind

From Old Into New

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

Become a Happy Customer

Join our community of over 500 Active Users 

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We selected PhlexSubmission because of the compliance guarantee...it gives us peace of mind.

Regulatory Affairs Manager, Germiphene

The fast support of Phlexglobal is understanding in this industry. Moreover, we like the intuitive user interface very much.

Head of Regulatory, Makrocare

We never thought that FDA compliance can be so easy and that the same time cost effective with an all-in-one annual fee.

Regulatory Specialist, Athenex

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Join these companies and more!

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 100% Compliance with Phlexglobal's eCTD Submission Software

 

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Be 100% eCTD Compliant

Use the Cunesoft guarantee for your first submission

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Training on using the ESG (Electronic Submission Gateway):

Speedy start-up, training and validation

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Work With the Right Tool

Use built in submission templates based on latest FDA/ICH requirements

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Assistance in setting up your FDA Account

Rely on Phlexglobal experience to work more efficiently

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Save Money

Make use of the cost control via an annual all inclusive subscription fee

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Get the job done

GxP aligned and fully validated

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Never Be Alone

Ongoing eCTD support via a 1 hour guaranteed response time

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Work Confidently

No system installation needed – we maintain a validated environment for you

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Use State-of-the-art Software

21CFR11 compliance via private SaaS (Software as a Service)

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Depend on Phlexglobal's experience:

Support to prepare the required eCTD test submission

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See for yourself - watch our video demonstration 

eCTD Software Demo PhlexSubmission_V2

 

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Get the details - Download the Data Sheet
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It's time to raise your standard 

CONTACT PHLEXGLOBAL TODAY
 
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