Latest Release AU-V2-1D

New XSD V3.1 is implemented with the changes as given in the guidelines in Submission Plan & File Attachment. New fields are added in the Submission plan along with the new sections.

Changed Look n Feel of the application to make it more User-Friendly…

You will feel like you are working on new Application. But it doesn’t mean that you need to learn it again… you will understand yourself as you start using the application.

Code master is also now more user-friendly. You can search existing codes on the same screen. This will help you to find out already present codes with same description in present in Dossier-Mgmt©.

Enhanced look for Submission Plan, auto generating and uploading of Life Cycle Management file to m1-0-2 tracking table section

Before uploading files, you can correct/verify /modify PDF documents. You can drop multiple files using Dropbox in Pre-FA as well as ‘Drop Box’ client tool which installed separately on every client machine. Once necessary actions are done, you can move those files for file attachment.

Link for Hyperlink is provided from web application. On click of Hyperlink icon application will redirect user to Hyperlink Tool.

Compilation and Verification process will be carried out with respect to Australian eCTD validation criteria 3.1. PDF Properties Correction and Verification will be done in web itself. User-friendly log report is provided with set of validation as per Australia

Modified Submission Verification report to display validations done as per validation criteria.

View menu allows user to view all the files attached in entire life cycle of submission.
In Sequence View user can view or open the uploaded/attached files from submission at any time irrespective of Submission status.
Cumulative View shows life cycle of all files throughout submission.
In Current View only active files from all sequences are displayed.

We have shifted Submission / Drug selection Key Screen to Footer panel which will be available all the time. You can change / view details of the selected submission at any moment. No need to select the same submission on all key-screens. On the same panel, you will be able to find details of submission like Drug Description, ISN, e-Identifier, Sequence number along with Submission Plan Status.

Click on the up-arrow Icon to expand key-search to Select/Load Current Submission Details

You can search for a Submission just by entering the value that you remember… like ISN / Root Directory Name / Drug Description. For this expand the ISN combo and type. Application will display filtered list for the text entered…

Elaborate Help file with screenshot to aid you on ‘How Part?’…

Latest Release CA-V2-1A

Changed Look n Feel of the application to make it more User-Friendly…

You will feel like you are working on new Application. But it doesn’t mean that you need to learn it again… you will understand yourself as you start using the application.

Code master is also now more user-friendly. You can search existing codes on the same screen. This will help you find out already present codes with same description in Dossier-Mgmt©.

Enhanced look for Submission Plan, auto generating and uploading of Life Cycle Management file to m1-0-2 section

Before uploading files you can correct/verify /modify PDF documents. You can drop multiple files Dropbox in Pre-FA as well as our Drop Box client tool. Once necessary actions are done, you can move those files for file attachment.

To aid you while creating file amendment or even applying delete operation on previously uploaded files is made easier. For this we have loaded cumulative view on the amendment screen itself. You can view complete life cycle of each and every file including its status [active / inactive / orphan] uploaded so far in the selected section / module. File amendment is also simple as simple as New file uploading. Application will automatically change the file status instantly.

Link for Hyperlink is provided from web application, on click of Hyperlink icon application will redirect user to Hyperlink Tool.

Compilation and Verification process will be carried out with respect to new CA validation criteria 4.2 and PDF properties correction and verification will be done in web itself and user-friendly log report is provided with set of validation as per Health Canada and corrective measures for respective errors are given.

View menu allows user to view all the files attached in entire life cycle of submission. In sequence view user can view or open the uploaded/attached files from submission at any time irrespective of Submission status. Cumulative view shows life cycle of all files throughout submission and in current view only active files from all sequences are displayed

Publish and Download activities are separate even though both are available in the same menu. Once the Submission Review is done and you want to finalize the Submission, then you need to ‘Publish’ it. In Publish activity, we perform all activities before the Submission is made available for Download process. In this activity, we also create zip file of your submission folder on Server. In download activity, you can download this zip file from server to client machine.

If the Submission is heavy and it’s taking lot of time to download, then with the help of your IT team, you can directly copy processed zip file from Server.

We have shifted Submission / Drug selection Key Screen to Footer panel which will be available all the time. You can change / view details of the selected submission at any moment. No need to select the same submission on all key-screens. On the same panel, you will be able to find details of submission like Drug Description, ISN, Root Directory Name, Sequence number along with Submission Plan Status.

Click on the Icon to expand key-search to Select / Load Current Submission Details

You can search for a Submission just by entering the value that you remember… like ISN / Root Directory Name / Drug Description. For this expand the ISN combo and type. Application will display filtered list for the text entered…

Now help file is available in PDF format in secured format.

Latest Release EU-V8-1A-P2

This validation criteria will come into force from 1st September 2018. This is a Mandatory Patch update.

You can change RMS as and when required. Accordingly, changes in tracking table will be adopted automatically and it will also get upload to cover section.

You can withdraw country in higher sequences as and when required. Accordingly, application will update tracking table.

Couple of validations are modified as per validation criteria.

Few bug fixes are done…

Changed Look n Feel of the application to make it more User-Friendly…

You will feel like you are working on new Application. But it doesn’t mean that you need to learn it again… you will understand yourself as you start using the application.

Re-arranged menus so that menus are process oriented… Now menu will drive user for ‘What Next?’

Code master is also now more user-friendly. You can search existing codes on the same screen. This will help you find out already present codes with same description in Dossier-Mgmt©.

We have shifted Submission / Drug selection Key Screen to Footer panel which will be available all the time. You can change / view details of the selected submission at any moment. No need to select the same submission on all key-screens. On the same panel, you will be able to find details of submission like Drug Description, ISN, Root Directory Name, Sequence number along with Submission Plan Status.

Click on the Icon to expand key-search to Select / Load Current Submission Details

You can search for a Submission just by entering the value that you remember… like ISN / Root Directory Name / Drug Description. For this expand the ISN combo and type. Application will display filtered list for the text entered…

Click on button on footer panel to load details of the Submission you are working on. You will get details of all sequences for the selected Submission…

• Once you login to application, it will display alert message to remind you that on which you were working and is selected for further activities. If you want to change the submission you were working on, you can change it from the Footer Key-search.

• 

Enhanced look for Submission Plan...

To aid you while creating file amendment or even applying delete operation on previously uploaded files is made easier. For this we have loaded cumulative view on the amendment screen itself. You can view complete life cycle of each and every file including its status [active / inactive / orphan] uploaded so far in the selected section / module. File amendment is also simple as simple as New file uploading. Application will automatically change the file status instantly.

Publish and Download activities are separate even though both are available in the same menu. Once the Submission Review is done and you want to finalize the Submission, then you need to ‘Publish’ it. In Publish activity, we perform all activities before the Submission is made available for Download process. In this activity, we also create zip file of your submission folder on Server. In download activity, you can download this zip file from server to client machine.

If the Submission is heavy and it’s taking lot of time to download, then with the help of your IT team, you can directly copy processed zip file from Server.

Now help file is available in PDF format in secured format.

Latest Release GCC-V2-1B

Latest Release JO-V3-1A

Code master is also more user-friendly. You can search existing codes on the same screen. This will help you scan already existing codes with same description in Dossier-Mgmt©.

An Enhanced look of Submission Plan, auto generating and uploading of Life Cycle Management file to m1-0-2 section is present.

Before uploading files into the submission you can correct/verify /modify PDF documents. You can drop multiple files in the Dropbox of Pre-FA and Drop Box of client tool as well. Once necessary process is driven, you can move those files to file attachment.

Link for Hyperlink is provided from web application. On click of Hyperlink icon application will redirect user to Hyperlink Tool.

Compilation and Verification process will be carried out with respect to Latest validation criteria and PDF properties correction and verification will be done in web itself. A user-friendly log report is provided with set of validation as per the regulatory corrective measures for respective errors are also provided.

View menu allows user to view files attached in the life cycle of a submission. In sequence view user can view or open the uploaded/attached files from submission at any point of time irrespective of Submission status. Cumulative view shows life cycle of the files present throughout submission and in the current view files in active state from all sequences are displayed.

Publish and Download are two separate activities even though both are available in the same menu. Once the Submission Review is done and you want to finalize the Submission, then you need to ‘Publish’ he submission. During Publish, we perform all the activities before the Submission is made available for Download process and a zip file is created of the submission on the Server. In download activity, you can download this zip file from server to client machine.

If the Submission is heavy and it’s taking lot of time to download, then with the help of your IT team, you can directly copy processed zip file from Server.

The Submission / Drug selection Key Screen in the Footer panel will be available anytime. You can change / view details of the selected submission at any moment. No need to select the same submission on all key-screens. On the same panel, you will be able to find details of submission like Drug Description, ISN, Root Directory Name, Sequence number along with Submission Plan Status.

You can search for a Submission just by entering the value which you remember… like ISN / Root Directory Name / Drug Description. For this expand the ISN combo and type. Application will display filtered list for the text entered…

Now help file is available in PDF and secured format.

Admin user will have access to Admin Activities only. Admin won’t be able view or access Submissions.

Latest Release ROW-V1-1B

Latest Release ACTD-V1-1B

NEES submission format has officially implemented for ASEAN, aligning with the latest regulatory guidelines issued by the asean.

User-Friendly Look n Feel

The application's look and feel offer a more user-friendly and intuitive experience. The interface is self-instructive, enabling users to navigate and utilize features with ease, even without prior training.

The application supports distinct user roles—Admin User, Super User, and Normal User—each with a dedicated dashboard tailored to their responsibilities. This role-based interface design helps reduce complexity and ensures a more streamlined user experience.

Additionally, the dashboard view enables users to easily track submissions and access detailed information about tasks they are currently working on or have previously handled, enhancing transparency and productivity.

This release is fully compatible with the latest versions of Microsoft Edge, Mozilla Firefox, and Google Chrome, ensuring a seamless experience across major web platforms.

The application flow is clearly segmented into distinct steps—Code Master, Submission Plan, File Attachment, Backend Process, and Publish & Download. This structured approach simplifies user interaction, enhances usability, and minimizes confusion or repetitive actions, making the overall experience more intuitive and efficient.

The output folder generated by the application is highly trustworthy, thanks to a robust backend process that strictly adheres to regulatory guidelines. This ensures that no compromises are made in meeting compliance standards, significantly reducing the risk of rejection from regulatory authorities such as the FDA. The system is designed to produce output that aligns precisely with regulatory expectations.

New functionalities such as PDF Correction, Pre-FA, and Drop-box integration have been added to streamline file attachment processes. These features significantly reduce the time and effort required for managing documents, making the application more efficient and user-friendly.

The application now includes several valuable features that enhance usability and compliance, such as Access Permissions, Cumulative View, Preview of Submission, Cumulative Inherit, and Audit Tracking. These additions provide users with greater control, transparency, and efficiency throughout the submission process.

The application now includes powerful tools such as the Submission Publishing Tool and Hyperlink Utility. These tools enhance the submission process by improving accuracy, reducing manual effort, and ensuring regulatory compliance.

Latest Release CH-V2-1C

Code master is also more user-friendly. You can search existing codes on the same screen. This will help you scan already existing codes with same description in Dossier-Mgmt©.

An Enhanced look of Submission Plan, auto generating and uploading of Life Cycle Management file to m1-0-2 section is present.

Before uploading files into the submission you can correct/verify /modify PDF documents. You can drop multiple files in the Dropbox of Pre-FA and Drop Box of client tool as well. Once necessary process is driven, you can move those files to file attachment.

Link for Hyperlink is provided from web application. On click of Hyperlink icon application will redirect user to Hyperlink Tool.

Compilation and Verification process will be carried out with respect to Latest validation criteria and PDF properties correction and verification will be done in web itself. A user-friendly log report is provided with set of validation as per the regulatory corrective measures for respective errors are also provided.

View menu allows user to view files attached in the life cycle of a submission. In sequence view user can view or open the uploaded/attached files from submission at any point of time irrespective of Submission status. Cumulative view shows life cycle of the files present throughout submission and in the current view files in active state from all sequences are displayed.

Publish and Download are two separate activities even though both are available in the same menu. Once the Submission Review is done and you want to finalize the Submission, then you need to ‘Publish’ he submission. During Publish, we perform all the activities before the Submission is made available for Download process and a zip file is created of the submission on the Server. In download activity, you can download this zip file from server to client machine.

If the Submission is heavy and it’s taking lot of time to download, then with the help of your IT team, you can directly copy processed zip file from Server.

The Submission / Drug selection Key Screen in the Footer panel will be available anytime. You can change / view details of the selected submission at any moment. No need to select the same submission on all key-screens. On the same panel, you will be able to find details of submission like Drug Description, ISN, Root Directory Name, Sequence number along with Submission Plan Status.

You can search for a Submission just by entering the value which you remember… like ISN / Root Directory Name / Drug Description. For this expand the ISN combo and type. Application will display filtered list for the text entered…

Now help file is available in PDF and secured format.

Admin user will have access to Admin Activities only. Admin won’t be able view or access Submissions.

Latest Release TH-V3-1D

New Country ‘Thailand’ is implemented which is following latest Regulatory guidelines as per XSD V 1.0.

Look and Feel of the application is User-friendly and Self instructive.

Separate User Roles like Admin User, Super User, Normal User are available with different dashboards which avoid complexity while using the application.

Also with the Help of Dashboard, User can easily view the submissions and respective details on which user was/is working.

The generated Output folder is trustable because of strong Backend compilation and verifcation processes which strictly follow the Regulatory guidelines and avoid any kind of compromises related regulatory requirements.

Additional Features are available like PDF Correction, Pre-FA, Drop-box in application which helps to ease the file attachments related activities which is time consuming.

Supportive reliable features also included in the application which add additional values while working on Application like- Access Permissions, Cumulative View, Preview of Submission, Cumulative Inherit, Audit etc.

Supportive Tools are also available like Submission Publishing Tool, Hyperlink, Independent Submission Verification Tool. These take care of Pdf properties verification and correction, hyperlinks within submission and verification of submission after it is downloaded outside the application.

Latest Release US-V8-1B

Before uploading files, you can correct/ verify/ modify PDF documents. You can drop multiple files using Dropbox in Pre-FA as well as ‘Drop Box’ client tool which will be installed separately on every client machine. Once necessary actions are done, you can move those files for file attachment. You can view, verify & correct different PDF properties. If required, you can perform corrections and reprocess the file to verify if all properties are corrected properly or not.

Compilation and Verification process will be carried out with respect to USFDA eCTD validation criteria. User-friendly log report is provided with set of validation as per US Validation Criteria.

Modified Submission Verification report to display validations done as per validation criteria.

View menu allows user to view all the files attached in entire life cycle of submission.
In Sequence View user can view or open the uploaded/attached files from submission at any time irrespective of Submission status.
Cumulative View shows life cycle of all files throughout submission.
In Current View only active files from all sequences are displayed

Admin user will have access to Admin Activities only. He / she won’t be able view or access Submissions. Also adopted new interface for User Management Screen.

Elaborate Help file with screenshot to aid you on ‘How Part?’, ‘FAQs’ & ‘Troubleshooting’.

Dossier-Mgmt© installation will be With OR Without SPT features i.e. Pre-FA, PDF Correction & PDF Verification. To embed these features in web application, you need to have separate license for the same.

Latest Release WHO-V1-1A

eCTD (electronic Common Technical Document) submission format has officially implemented for WHO using DTD Version 1.0, aligning with the latest regulatory guidelines issued by the PQT.

The application's look and feel offer a more user-friendly and intuitive experience. The interface is self-instructive, enabling users to navigate and utilize features with ease, even without prior training.

The application supports distinct user roles—Admin User, Super User, and Normal User—each with a dedicated dashboard tailored to their responsibilities. This role-based interface design helps reduce complexity and ensures a more streamlined user experience.

Additionally, the dashboard view enables users to easily track submissions and access detailed information about tasks they are currently working on or have previously handled, enhancing transparency and productivity.

This release is fully compatible with the latest versions of Microsoft Edge, Mozilla Firefox, and Google Chrome, ensuring a seamless experience across major web platforms.

The application flow is clearly segmented into distinct steps—Code Master, Submission Plan, File Attachment, Backend Process, and Publish & Download. This structured approach simplifies user interaction, enhances usability, and minimizes confusion or repetitive actions, making the overall experience more intuitive and efficient.

The output folder generated by the application is highly trustworthy, thanks to a robust backend process that strictly adheres to regulatory guidelines. This ensures that no compromises are made in meeting compliance standards, significantly reducing the risk of rejection from regulatory authorities such as the FDA. The system is designed to produce output that aligns precisely with regulatory expectations.

New functionalities such as PDF Correction, Pre-FA, and Drop-box integration have been added to streamline file attachment processes. These features significantly reduce the time and effort required for managing documents, making the application more efficient and user-friendly.

The application now includes several valuable features that enhance usability and compliance, such as Access Permissions, Cumulative View, Preview of Submission, Cumulative Inherit, and Audit Tracking. These additions provide users with greater control, transparency, and efficiency throughout the submission process.

The application now includes powerful tools such as the Submission Publishing Tool and Hyperlink Utility. These tools enhance the submission process by improving accuracy, reducing manual effort, and ensuring regulatory compliance.

Latest Release ZA-V1-1A

Changed Look n Feel of the application to make it more User-Friendly…

You will feel like you are working on new Application. But it doesn’t mean that you need to learn it again… you will understand yourself as you start using the application.

Re-arranged menus so that menus are process oriented… Now menu will drive user for ‘What Next?’

Code master is also now more user-friendly. You can search existing codes on the same screen. This will help you find out already present codes with same description in Dossier-Mgmt©.

We have shifted Submission / Drug selection Key Screen to Footer panel which will be available all the time. You can change / view details of the selected submission at any moment. No need to select the same submission on all key-screens. On the same panel, you will be able to find details of submission like Drug Description, ISN, Root Directory Name, Sequence number along with Submission Plan Status.

Click on the Icon to expand key-search to Select / Load Current Submission Details

You can search for a Submission just by entering the value that you remember… like ISN / Dossier Identifier / Drug Description. For this expand the ISN combo and type. Application will display filtered list for the text entered…

Click on button on footer panel to load details of the Submission you are working on. You will get details of all sequences for the selected Submission…

• Once you login to application, it will display alert message to remind you that on which you were working and is selected for further activities. If you want to change the submission you were working on, you can change it from the Footer Key-search.

• 

Enhanced look for Submission Plan...

To aid you while creating file amendment or even applying delete operation on previously uploaded files is made easier. For this we have loaded cumulative view on the amendment screen itself. You can view complete life cycle of each and every file including its status [active / inactive / orphan] uploaded so far in the selected section / module. File amendment is also simple as simple as New file uploading. Application will automatically change the file status instantly.

Publish and Download activities are separate even though both are available in the same menu. Once the Submission Review is done and you want to finalize the Submission, then you need to ‘Publish’ it. In Publish activity, we perform all activities before the Submission is made available for Download process. In this activity, we also create zip file of your submission folder on Server. In download activity, you can download this zip file from server to client machine.

If the Submission is heavy and it’s taking lot of time to download, then with the help of your IT team, you can directly copy processed zip file from Server.

Now help file is available in PDF format in secured format.