Corporate Overview
If your goal is to author documents easily, compile electronic submissions efficiently, shorten drug development timelines, and reduce operating costs, Omnicia provides one integrated electronic publishing solution that will make it happen.
Omnicia, a privately held corporation founded in 2001 by experienced and respected electronic publishers, provides software solutions and professional services to compile electronic submissions for the Life Sciences Industry.
Omnicia combines feature-rich technology with a wide range of professional services to help companies effciently compile electronic submissions and meet drug development deadlines.
Omnicia’s unique service-provider approach brings submission preparation costs down to earth.
Small and medium-sized companies now have access to authoring and electronic publishing automation previously affordable only to larger companies with deep pockets. Large companies now have an electronic publishing alternative that will reduce existing overhead and submission compilation time.
Omnicia’s Expertise: Experienced and Respected Professionals
Our management team has over forty years of combined experience supporting leading biotech, pharmaceutical, and medical device companies in:
Fully electronic, hybrid and paper publishing.
Electronic guidance interpretation and implementation.
FDA electronic submission negotiation.
Document management and record retention operations.
Regulatory affairs and clinical operations.
21 CFR Part 11 interpretation and implementation.
Technology development, implementation, and validation.
Omnicia’s Technology: Authoring and Electronic Publishing Solutions
OmniTEMPLATE™ - Intelligent Document Creator
Intelligently designed style and content templates that effciently create report, protocol, SOP, IND, eCTD, eBLA, eNDA, 510k, PMA, Amendment and Supplement documents.
OmniFILE Publishing System™ - Intuitive Electronic Submission Compiler
Intuitive software that electronically publishes compliant documents, reports, protocols, INDs, eCTDs, eBLAs, eNDAs, 510ks, PMAs, Amendments and Supplements for US and EU regulatory agency review while supporting viewing of eCTD M1 and study tagging file indices.
OmniFILE Suite™ - Robust Electronic Publishing Package
Robust, bundled package includes OmniTEMPLATE™ and OmniFILE Publishing System™ that supports the electronic publishing activities from creating documents through compiling electronic submissions.
Omnicia’s Professional Services: Experienced and Respected Professionals
OmniASSIST™ develops and implements document management and electronic publishing infrastructures that complement a company’s culture.
OmniASSIST experts can help in every phase of drug development. Our services include:
- Fully electronic, hybrid and paper publishing.
- Format and content template design and customization.
- Case Report Form (CRF) and legacy document scanning, bookmarking and hyperlinking.
- Electronic Document Management System (EDMS) implementation, validation and publishing system intergration.