SUBMISSION PUBLISHING SOLUTIONS

FOR THE LIFE SCIENCES

AFFORDABLE, FULL-FEATURED ELECTRONIC PUBLISHING

FOR COMPANIES OF ALL SIZES

A DEDICATED TEAM

FOR QUALITY, COMPLIANT SUBMISSIONS

Our Company

Omnicia was founded in San Francisco's Biotech Bay in 2001 by life sciences industry veterans looking to simplify the increasingly complex global electronic submission process with innovative software solutions and expert consulting services. Our intuitive software electronically creates, publishes, and views compliant documents, reports, and eCTD submissions for US, EU, and CA review. Omnicia's integrated solution simplifies document creation and electronic publishing. Our product features reduce the high costs traditionally associated with file preparation and submission publishing to a more reasonable level for companies of all sizes.

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.

Our Products

omniFILE

omniFILE elegantly publishes documents, reports, and eCTD submissions for US, EU, and Canadian review.

omniVIEW

omniVIEW is a cloud-based eCTD lifecycle viewing and validating system. Everyone's been asking for it and now it's coming.

omniASSIST

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.

omniTEMPLATE

omniTEMPLATE is our granular authoring package built to streamline document creation.

Wayne Leonard

Chief Financial Officer and Co-Founder

Wayne has over 28 years of experience in the pharmaceutical, biotech, and medical device industry. Wayne’s expertise in regulatory submissions operations, electronic document management, compliance, client support services, and sales were instrumental in creating and growing Omnicia's Professional Services group. Wayne ran Omnicia's Professional Services operations for well over a decade and has recently transitioned to the new role of Business Administration and Corporate Compliance.

Reuben K. Jenkins

President and Chief Executive Officer, Co-Founder and Board Member

With more than fifteen years of experience in the medical device and biopharmaceutical industry, Reuben Jenkins co-founded Omnicia, Inc. in 2001. As President and CEO in early 2002, Reuben has steered Omnicia to constant growth and innovation. He works closely with his executive management team and industry professionals in shaping Omnicia’s future strategies. Reuben Jenkins is a successful engineering graduate and entrepreneur who helped Omnicia move to the forefront of its complex, fluid, and fast-moving electronic regulatory field.

Peachy Dimanlig

Chief Operating Officer, Co-founder and Board Member

Peachy co-founded Omnicia in 2001. With over 18 years of experience, Peachy has used her expertise in electronic publishing operations, electronic document management, and client support services to develop a truly intuitive and elegant software suite that easily adapts to the quickly evolving requirements of US, EU, and CA agencies. Peachy's efforts in education and support services with our clients world-wide are cementing Omnicia's position as a leader in technical support for the electronic publishing industry.