PhlexSubmission

A Complete Submission Publishing Solution for Life Sciences

Complete lifecycle management of your regulatory documents and submissions in eCTD, NeeS, VNeeS and beyond

Compliant. Fast. Successful.

PhlexSubmission is a robust, easy-to-use document and submission management solution for electronic submissions standards such as eCTD, NeeS, and VNeeS. PhlexSubmission can also 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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Global Coverage  

Submit your INDs, variations, annual reports, NDAs, MAs, ASMFs and DMFs worldwide
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Outstanding Expert Support

We promise you a 100% eCTD compliance guarantee
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Fully
Validated to Support Your Compliance

Always be prepared for an FDA audit

 

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Expert Services: Our Secret To Your Success

 

When you have a question, ask Phlexglobal.

 We know that eCTD is new to many people and can be difficult to understand. Our support team are expert submission publishers themselves and always there to help.

  • 20x5 support availability
  • 1 hour response time
  • Technical support services

  • Regulatory support 
  • Adhoc user training
  • eCTD Compliance Guarantee

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.

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Like Nothing You've Seen Before

 

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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. 
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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.
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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.
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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.

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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, 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

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 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

Meet VERA

The Virtual Electronic Realtime Assistant. 

VERA is ready to guide you on your regulatory journey.

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 Phlexglobal 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

Request a Free Demo

 

See for yourself - watch our video demonstration 

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Get the details - Download the Data Sheet

VNees

Phlexglobal can help you meet Veterinary Non eCTD electronic Submission Requirements

Learn More

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It's time to raise your standard 

CONTACT PHLEXGLOBAL TODAY
 
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