Testimonials
"I have worked with the Omnicia team prior to the company's inception in 2001. Their knowledge and experience with electronic submission compilation, including use of the OmniFILE Suite publishing software, played a major part in the successful filing of regulatory applications to the US-Food and Drug Administration. When they asked me to support their Beta program, I jumped at the chance to participate and decided to use the OmniFILE Suite to compile two NDAs in CTD format. Although electronic publishing was new to Connetics and would present risks and challenges, I knew their knowledge and experience was built into the product. OmniFILE Suite did not disappoint."
Chuck Democko, VP Regulatory Affairs, Connetics Corporation
"In using Omnicia's OmniFILE, we found that the installation process is quite simple and efficient; the program is very user friendly; and the customer technical support is very, very good. I love the system. It helps/makes my job a lot easier."
Rachel Harrington, Technical Publisher, Phoenix Regulatory Associates Ltd
"I would like to extend my personal thanks and appreciation to Omnicia for all the help and guidance during our 'crunch period'. The team operated with the utmost professionalism and patience and worked long hours to ensure success. Most impressive is Omnicia's ability to problem-solve 'on the fly'."
Carole Stallings, Manager Regulatory Documentation, SuperGen
"Omnicia is about getting the job done. They assessed our situation, developed a project plan and worked with Clinical, Regulatory, IT and our FDA contacts to ensure all of the elements where in place to produce a compliant CTD. When we needed resources, Omnicia provided experienced personnel who seamlessly integrated with our in-house staff.
Without Omnicia's OmniFILE software and professional services, we would not have met our submission deadline."
Sheldon Mullins, Director Regulatory Affairs, SuperGen
We are a small company that needed to publish a CTD in a very short timeframe. We found the Omnicia team to be a very dedicated group. Without their help we would not have been able to meet our filing goals.
Tom Ottoboni – Vice President Strategy and Operations – Point Biomedical
Omnicia Inc. is the most knowledgeable, intelligent, and talented group of people working in the industry today. Their software is life saving, and their support is out of this world. They have never let me down.
Michael Barnotes – Electronic Publishing Specialist – Connetics Corporation
We purchased OmniFILE in 2004 and have successfully published two (2) eCTDs. Omnicia has developed an intuitive software package that streamlines compilation activities and works in concert with the drug development process. Because of their expertise and flexibility, we continue to use Omnicia to augment our publishing staff.
Wayne Davis – Senior Vice President Clinical Research – Supergen
We were excited to discover Omnicia because it is an affordable way for us to develop Electronic submissions (eCTD) in-house. The software's plug-ins truly make life easier during the development process, and the Omnicia staff has expertise in all subjects surrounding the eCTD process.
Victor Hall – Senior Manager MIS - Intarcia