PEGMAPHARM ECTD MANAGEMENT SYSTEM.

Regulatory compliance made easy through a complete web platform enabling you to build, manage, trace, import and export eCTD submissions in accordance with ICH and multiple regional specifications.

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Regulatory business, eCTD format, PegmaPharm solution

Regulatory challenge:
eCTD standard format for all procedures

Usually, change is a difficult process, but it stands as foundation for development and growth.

When eCTD started to become a standard regulatory format for different procedure types in multiple areas around the world, most Pharmaceutical companies were not prepared and worried about how they will address the situation.

Now it became obvious that, if you choose the right tools, the usage of eCTD standard can save a lot of time and financial resources. In the same time this can lead to reducing the human error risk to the minimum level.


Choose the right regulatory solution

The first question when it comes to implementing a new solution is ‘What do we need?’. Well, as usual, you should look for some basic attributes:

100% eCTD specification compliant

By making a real-time step-by-step validation according to ICH and M1 regional specifications, PegmaPharm ensures the guarantee to obtain only valid submissions.

Increase productivity and ROI

A customer-oriented approach, pipelined processes, and regulatory knowledge gathered together by PegmaPharm are meant to minimise involved time and financial resources, while increasing the technical accuracy and security level.

Improve work process

A great user experience. This is the first thing that our customers are mentioning about PegmaPharm. The intuitive interface and pipelined process, together with functionalities like bulk import, multiple files import, sequence reusing and real-time validation makes PegmaPharm a tool that almost anyone can use to create eCTD sequences in a glance.

Comprehensive and easy to integrate

Regulatory sequence and dossier management, including creation, editing, complete life cycle, import and export, combined with additional functionalities, like users and rights management, tasks allocation and supervising or internal chat are making Pegmapharm a complete regulatory solution, that can easily be integrated into any existing environment.

 

What’s covered

The unique dynamic architecture of PegmaPharm allows implementation of any eCTD format with minimum effort. Basically, in just a few days, a completely new format can be implemented based on given specifications.

Covered areas

  • EU - All national EU agencies, Centralised, MRP (Mutual Recognition Procedure), DCP (Decentralised Procedure)
  • GCC - Saudi Food and Drug Authority
  • CH - Swiss Agency for Therapeutic Products
  • US - US Food and Drug Administration
  • CA - Health Canada
  • EAEU even if this is not properly eCTD format, Pegmapharm is ready for the launch in 2021

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PegmaPharm eCTD management features

For the last ten years, based on a strong collaboration with our customers and regulatory consultants, PegmaPharm constantly improved by focusing on user experience, while staying compliant with ICH and Regional specifications.

eCTD validation

Structure and Data real-time validation according to ICH, 21CFR11 and Regional specifications.

Life Cycle Management

Complete Life Cycle viewer and manager, to track all submission changes.

Submission Import

Create submissions instantly by importing from eCTD, NeeS or folder structure.

Convert submission

Automatic conversion from eCTD to NeeS or paper format.

eCTD publishing

Export valid submissions as eCTD or NeeS archive ready for publishing.

eCTD viewer

Preview and validate eCTD submissions resulted from other regulatory tools.

PDF management

Automatic PDF version Validation and external PDF links validation.

Fast build

By using features like Mass upload, Sequence re-usage, Submission or Envelope cloning.

Backbone generation

Automatically build and validate compliant backbone file

Pipelined process

As long as the system won’t let you make mistakes, you will not need to fix them later

PegmaPharm Presentation

To find out more details about PegmaPharm modules and features, please download the PDF presentation.

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What 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.

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All-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.

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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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