Have it all together in one system! Use PegmaPharm for creating and managing compliant NeeS and VNeeS submissions in accordance with ICH and multiple regional specifications.
Although eCTD format is more complete and required in most areas, there are still agencies accepting also, or even only NeeS format for human medicines regulatory submissions. Also, for veterinary medicines, eCTD is not implemented, and VNeeS structure is used all over the world.
The main functionality of the PegmaPharm NeeS manager is the creation of valid Non-eCTD Electronic Human and Veterinary Submissions, along with hyperlinked TOC automatic generation.
Real-time step-by-step validation according to ICH and M1 regional NeeS/VNeeS specifications, resulting in compliant submissions.
Pipelined processes, real-time validation, automatic TOC generation, mass upload and many other features putted together to obtain a fast and accurate solution to quickly build human and veterinary Non-eCTD Electronic Submissions
Manage all regulatory submission formats in one place. Convert to and from NeeS, export in different formats. Compliant with multiple regulatory standards, for multiple regions.
PegmaPharm’s flexible architecture allows implementation of any NeeS or VNeeS format with minimum effort and no codding intervention.
Structure and Data real-time validation according to ICH and Regional specifications.
Automatically generate Table Of Content files according to official specifications.
Import existing submission or content from folder structure
Instantly convert from eCTD or Paper CTD to NeeS
Export valid submissions as NeeS archive ready for publishing
Automatic PDF version Validation and external PDF links validation
By using features like Mass upload, Sequence re-usage or Submission cloning
To find out more details about PegmaPharm modules and features, please download the PDF presentation.
Download PresentationThe 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.
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.
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 quotationIf 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.
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.
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.
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