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US Food and Drug Administration (FDA) Selects Octo for $300M Drug Resource Management System Development Contract

RESTON, Va.--(BUSINESS WIRE)--

Octo Consulting Group (Octo), an award-winning provider of technology and modernization services to the Federal government, announced they were one of just two companies awarded an unrestricted, seven-year, $300 million BPA contract by the US Food and Drug Administration (FDA) to meet requirements outlined in the 21st Century Cure Act (H.R.34) which mandates a more streamlined and efficient drug and device approval process.

To meet this Congressional mandate, the FDA’s Center for Drug Evaluation and Research (CDER) Office of Business Informatics (OBI) has turned to Octo to support a comprehensive suite of strategic capabilities and processes, and management of an underlying data analytics technological platform that will streamline and enhance the regulatory, surveillance, compliance, and enforcement oversight of pharmacological and biological therapeutic drugs.

Octo will partner with CDER to enhance and extend the agency’s drug evaluation processes including human drug data submission, management, governance and review; full application lifecycle development, operations and maintenance support; and training support. Octo will maintain and modernize the CDER Informatics Platform used by the agency to execute the entire lifecycle of the drug approval process.

“We are honored to be selected by the FDA to meet the needs of a project of this scope and mission of this importance,” said Mehul Sanghani, Octo’s Chief Executive Officer. “We see this unrestricted contract win as validation that agencies are continuing to look to modernization and technology partners like Octo who provide proven expertise with the agency’s mission and the specialized technical depth necessary to deliver the next-generation data management and data analytics capability at the velocity the agency demands.”

Octo was chosen in part due to its significant past performance with complex, large-scale data management and data analytics projects in large BPA settings at the National Institutes of Health (NIH), United States Patent and Trademark Office (USPTO), and the U.S. Army. Additionally, Octo will apply its SEI CMMI Level 4 appraised processes to drive agile processes, proven quality management and technical assurance in all its development approaches. For this engagement, Octo will leverage a strong team of industry partners, bringing the best in large data management, bioinformatics, and health policy to the fold.

About Octo Consulting Group
Octo is an industry-leading, award-winning provider of technology and modernization services for the Federal Government. Octo specializes in providing agile software development, user experience design, and cloud engineering services that address the government’s most pressing missions and modernization challenges.

Octo is one of only 11 private companies in the United States to have been appraised at CMMI® Level 4 for Software Development Maturity (CMMI-DEV). Additionally, Octo maintains ISO 9001, ISO 20000, and ISO 27001 certifications and is one of only seven government contractors that is a Scaled Agile Framework (SAFe®) Gold Partner: an industry-accepted framework for developing software applications using Agile development principles.

Headquartered in Reston, Virginia, Octo has additional offices in Alexandria, Virginia and Columbia, Maryland. Learn more at octoconsulting.com.

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