Generating eCTD and NeeS submissions with minimum effort
Designed with an intuitive, user-friendly interface, putting together differnt additional functionalities and using adanced technology, PegmaPharm manages to
provide a secure and simple way to create and manage eCTD and NeeS dossiers.
Being on the market since 2009, the tool was not only updated to latest specifications, but also constantly improved to obtain the best user experience, by simplifying and speeding up the process
Use the advantages of a
mature and complete software
- Export submissions in eCTD and NEES format
- Constantly updated based on ICH and EMA specifications
- Complete Life Cycle Management
- Import submissions from other applications
- Re-using data from previous submissions
- System users and rights management
- User friendly visual interface
- Built-in communication between users
- Fast and simple implementation process
- Secure but accessible web application
Structure and Data validation
In order to speed up the process, PegmaPharm does most structure validations in real time.
There are limitations and validations on every step, so that you do not need to finalise a module or the entire submission before knowing that you misplaced something.
Respecting ICH standard structure and regional regulation, the application is generating ready-to-use eCTD and NeeS submissions, complying the official Lorenz Validator.
Complete Life Cycle management
According to ICH recommendation, PegmaPharm is keeping track of all changes from one submission to another.
This way, you can have a complete view of what whas added, replaced, appended or deleted from the first sequence until the current one and check the origin and path of each sequence.
Active Control and Security
Standard user login, based on encripted uniques credentials, offers a reliable level of security.
The User Management module, together with the Project Team Management functionality for each dossier provides a secure process, limiting the access to sensitive information and minimising the risk of data loss.
User Friendly interface
The secret of a happy user is to offer him the minimum amount of tools that can lead him to the expected result, without overloading the process.
By keeping things simple and eliminating as many unnecessary actions as possible, we managed to provide an user-friendly interface and a straight-forward process, easy to learn and use.
Automatically Import submissions and dossiers
You have dossiers or sequences created with another tool and you need to use them? Just import them into PegmaPharm.
If a submission is incomplete or not correct, depending on the situation, you will get wornings or errors and you will be guided through the necessary changes.
Bulk Importing from structure
If you already have a complete or partial CTD structure and you are wondering if there is a way to import it all, with the new Import from Structure functionality, it is now possible.
All files located and named accordingly to ICH specification will be imported from your structure and you will be notified on the mismatches and missing parts.
Complete actions history
In order to minimise the risk of human error, the application is keeping references of all actions on each sequence.
The supervisor is given an important leverage, by being able to review actions history filtered by user, submission or action type.
Internal communication
One of the key factors in all projects and activities is communication.
A comprehensive Tasks Management module, completed by an Internal Messaging functionality provide an interactive and traceble communication environment, a leverage for users and supervisors.
Best quality-price ratio
Having in mind the needs of small and medium Pharmaceutical Manufacturers we strongly believe that we managed to provide the best quality-price ratio on the market, by eliminating useless features and maximising efficiency.
