Octo Consulting Wins $300M BPA To Update FDA Drug and Device Approval

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Mehul Sanghani, Octo Consulting Group, Inc.

Mehul Sanghani, Octo Consulting Group, Inc.

Octo Consulting Group is one of two companies awarded a $300 million blanket purchase agreement contract to help the Food and Drug Administration implement a more streamlined and efficient drug and device approval process.

The contract aims to help FDA meet requirements outlined in the 21st Century Cure Act, signed into law in December 2016.

Octo Consulting will work with the FDA Center for Drug Evaluation and Research’s Office of Business Informatics, supporting a data analytics platform that will streamline and enhance the regulatory, surveillance, compliance and enforcement oversight of pharmacological and biological therapeutic drugs, Octo said.

The company’s work will 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 CEO. “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 has past experience with complex, large-scale data management and data analytics projects in large BPA settings, through previous work with the National Institutes of Health, the Patent and Trademark Office and the U.S. Army, the company said. For the current BPA, Octo will work with a team of industry partners, bringing additional capability in large data management, bioinformatics, and health policy to the fold, the company said.

The BPA has a 7-year period of performance.

Octo recently won agile development contracts with the Centers for Medicare and Medicaid Services and the Justice Department. Sanghani delivered the keynote address at the Virginia Tech commencement ceremony in 2017.

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