OmniTEMPLATE is a comprehensive, intelligently designed authoring package built specifically for streamlining the document creation process while meeting the industry standards for ICH granularity. Using our document wizard, custom styles, toolbars, and macros you can easily customize your documents to meet your needs. We are leading the charge to simplify eCTD publishing by rejecting the rehashed industry standard. Instead of juggling hundreds of document templates we have designed omniTEMPLATE to create the hundreds of eCTD documents required to support global submissions with only nineteen templates. Our system automates the document creation and formatting process. ICH-CTD file naming, alpha-numeric auto-numbering, header and footer custom attribute population, US letter to A4 page conversion and table formatting are just some of the features available to authors.

OmniFILE elegantly publishes documents, reports, and eCTD submissions for US, EU, and CA review. OmniFILE reduces implementation, validation, and ongoing system maintenance for the IT department and eliminates the need for never-ending consulting support and costly software as a service offerings. We built omniFILE with the publishers in mind. They can insert internal and external hyperlinks into Microsoft Word documents using a batch process. It is no longer necessary to go through the hassle and risk of hyperlinking one citation at a time or inserting external hyperlinks on the rendered PDF document. Publishers can create reports and submissions using one integrated product that is intuitive and flexible.

OmniVIEW is a stand-alone desktop application that supports eCTD lifecycle viewing and validating at any stage of drug development. We optimized our software specifically for the demands of loading large quantities of submission sequences. Our multi-panel browser-like interface presents lifecycle information in an intuitive and easily navigable way. Our task pane presents leaf information and lifecycle details in a clean and easy to read manner. This includes links to quickly view eCTD lifecycle attributes, launch referenced leafs, or open eCTD folders. OmniVIEW is fully compliant with all US, EU, and CA eCTD specifications. We offer omniVIEW with both eCTD view-only capabilities or with eCTD view and validation capabilities.

In addition to our software solutions, Omnicia has a team of experienced professionals ready to assist sponsors at every stage of the document creation, formatting and publishing process. With omniASSIST you can count on a wide range of services specifically tailored to help achieve your goals. Our experts have a proven track record of success and can help in every phase of the drug development process.