Complete regulatory electronic submission management
Build
Have the best user experience by taking advantage of PegmaPharm technology and know-how to quickly build compliant regulatory submissions with minimum knowledge necessary.
Manage
A set of tools will help you manage regulatory submissions and dossiers, like sequence re-usage, track of changes, work management, NEES to eCTD transformations and more.
View
Review dossiers and submissions, history of changes, life cycle, actions by users, check status and validation logs in a simple, user-friendly graphical interface.
Validate
Step-by-step validation and final validation report for structure, naming and usage rules, according to ICH and regional specifications, complying official validation rules.
Import/Export
Import, validate, transform and create dossiers from existing eCTD or NEES submissions generated with any other system. Export sequences for Agency submission.
Lifecycle
Keeping entire lifecycle history from initial submission until current one, PegmaPharm offers the possibility to track changes on entire dossier, modules, sub-modules or files.
Regulatory
for everyone
The easy way!
Building and validating compliant electronic submissions comes with a set of challenges even for the best regulatory experts. This is why we tried to make it simple for everyone, even with minimum knowledge in this area.
Putting together our experience, knowledge of multiple regulatory consultants and feedback from our customers, by constantly improving during the last ten years, PegmaPharm claims to offer the best user experience for building regulatory submissions.
Practically, anyone should be able to use it with minimum technical knowledge.
If you are looking for a regulatory solution, or even if you are already using a different system, it will cost you nothing to give it a try!
Request a demoPegmaPharm Presentation
To find out more details about PegmaPharm modules and features, please download the PDF presentation.
Download PresentationWhat makes the difference...
Flexible and reliable
The dynamic and configurable structure, based on ICH, 21CFR11 and Regional specifications and validation criteria gives PegmaPharm the great advantage of being able to quickly adapt to any changes or even completely new format with minimum intervention.
Never alone
Having at your disposal the maintenance technical support, our regulatory consultancy partners, our experience on the market and our general customer-oriented business approach will make you feel like having a reliable partner, instead of a simple service provider.
Money saver
By getting together the most useful functionalities for regulatory software applications and offering different licencing plans for any business of any size, we proudly believe that PegmaPharm is offering the best price-quality ratio on the market.
Request a quotationAll-in-One
If you are searching for a complete regulatory tool, PegmaPharm could be the solution. Managing all known Regulatory formats for most areas in the world, while giving also the possibility to define new structures in a secure but accessible environment, PegmaPharm should cover all regulatory needs, completed by additional features like tasks and users management, activity logs or internal communication module.
Mature & Tested
Since 2009, PegmaPharm has been serving Pharmaceutical companies and Regulatory consultants for generating compliant regulatory sequences to be submitted to different Agencies. All this time, it did not only adapt to every ICH and Regional specification changes, but also constantly improved all functionalities and the user experience.
Request a Demo
If you would you like to find out more about PegmaPharm and our services, please click the button below and fill out our contact form.
Request a demo