We are honored to have been selected to play a role in the support of this heroic effort by the Office of the Assistant Secretary for Health (OASH) to expand COVID-19 testing in local communities.
ROCHELLE, Va. (PRWEB) January 12, 2021
NDA Partners President, Earle Martin, announced today that the company has been awarded a contract with the US Department of Health & Human Services, Office of the Assistant Secretary for Health (OASH), to conduct technical and regulatory reviews of applications for Emergency Use Authorizations (EUAs) submitted for laboratory developed tests (LDTs) for COVID-19, with the objective of assisting OASH in expanding the availability of COVID-19 diagnostic testing in local communities. NDA Partners is part of The Planet Group (TPG), a global provider of outsourced human capital solutions and expert consulting.
The EUA review services will be conducted by NDA Partners in collaboration with Treximo, TPG’s life sciences division. The scope of services includes reviews of EUAs submitted for COVID-19 LDTs, including tests that combine detection of COVID-19 with other respiratory pathogens, and written assessments of those applications that will provide OASH with information to support its final evaluation of the EUAs and authorization decisions.
In addition to the EUA reviews, NDA Partners will act as advisors to OASH and provide consultation and recommendations related to the program goals and objectives, processes and procedures, and other high-level strategic guidance that may improve program efficiency and outcomes. Advisory services will be provided by two senior Partners in the firm, Alberto Gutierrez, PhD, former Director of the Office of In Vitro Diagnostics and Radiological Health at the FDA and David Feigal, MD, MPH, former Director of the Center for Devices and Radiological Health at the FDA.
“We are honored to have been selected to play a role in the support of this heroic effort by the Office of the Assistant Secretary for Health (OASH) to expand COVID-19 testing in local communities,” stated Mr. Martin, “and look forward to initiating this program immediately to help reduce the backlog of EUAs awaiting review and approval.”
The Planet Group
The Planet Group (TPG) is a global provider of outsourced human capital solutions and expert consulting. TPG (theplanetgroup.com) was founded in 2009 and is headquartered in Chicago, Illinois. The company provides services across the professional services sector including the life sciences, diversified energy, engineering, financial, healthcare, IT, and digital marketing industries. TPG’s life sciences consulting services are delivered through its two subsidiary companies, NDA Partners and Treximo.
NDA Partners (ndapartners.com) is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Partners and Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former regulatory agency and pharmaceutical industry senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.
Treximo (treximo.com) provides regulatory consulting, medical writing, quality assurance, clinical outsourcing, customized functional teams, and clinical trials management services to support pharmaceutical, biotechnology, and medical device companies through the entire product development life cycle. Access to TPG’s substantial recruiting and staffing services enables Treximo to take on projects of any size, staff them with qualified experts in the required functional areas, assemble project teams in a timely manner, and deliver services of the highest quality.
Earle Martin, President