AXON Research

"From Thought to Action"

Building Solutions to Information Challenges of the 21st Century

 
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CSV Compliance
Software and Databases
Regulatory Documentation
Quality and Process

Regulatory Documentation

 

Regulatory practices must create, manage, and maintain a reliable repository of data, treated both as documents (display form is relevant) and as records (managed according to defined business requirements and processes).

 

Managing the necessary documentation for regulatory compliance AND preparing submissions to regulatory agencies are demanding tasks... and many organizations use assistance in this area.

 

AXON Research has been active in innovation in this area, and offers substantial expertise to its clients. 

 

Consider AXON Research when...

 

you are considering the adoption of systems for document management or submissions

 

you can use some assistance in understanding regulatory guidance and underlying processes

 

the quantity of work is overwhelming - project management and new technology are available 


...we can help you achieve more!

 

 

ICH
International Conference on Harmonization

It is possible to unify the generation of submissions for the US, EU, and Japan thanks to ICH.

 

CTD
Common Technical Document for Registration of Pharmaceuticals for Human Use

Documentation organized according to the CTD can be sent to multiple regulatory agencies.

 

XML
eXtensible Markup Language

XML is a technical tool that allows the management and submission of electronic data and documentation with attached descriptions that enable whole new realms of opportunity.

 

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