The Department of Health and Human Services Food and Drug Administration (FDA) awarded a sole-source, firm fixed-price purchase order contract to Nexight Group LLC, a regulatory consulting firm, to provide Standards Development for Regenerative Medicine Therapies. The contract has a potential value of $936,040.00 and a completion date of July 30, 2020. The FDA determined that Nexight Group's existing deliverables and expertise were required to ensure consistency and integrity of the overall...
The Department of Health and Human Services Food and Drug Administration awarded a firm fixed price purchase order to Nexight Group LLC, a regulatory consulting firm, for the development of standards for regenerative medicine therapies. The $2,921,928.00 contract supports the modification of an existing contract to add a workshop on reference materials and standards, publish fact sheets, and summarize relevant standards. Nexight has already established an organization of stakeholders and...
This is a delivery order contract awarded by the Food and Drug Administration (FDA) to Nexight Group LLC, a small business regulatory consulting firm based in Silver Spring, Maryland. The contract supports the FDA's Standards Recognition Program for Regenerative Medicine Therapies (SRP-RMT) by coordinating activities to enable the development of needed standards through engagement with regenerative medicine stakeholders. The contract has a ceiling value of $2,070,480.00 and a completion date...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a $4,122,028.80 delivery order contract to Koniag Management Solutions LLC to obtain eight scientific contract professionals to support the research program of the FDA's Center for Drug Evaluation and Research, Office of Biotechnology Products. The contract is for a base period of performance from June 24, 2022 to June 26, 2025 in Silver Spring, Maryland and utilizes a labor hours pricing structure.
The Department of Health and Human Services Food and Drug Administration awarded a $2.3 million delivery order contract to Dnanexus, Inc. for Increment B of PrecisionFDA. Dnanexus will provide labor hours to further develop PrecisionFDA, an FDA initiative that applies bioinformatics and computational biology to regulatory science. The one-year contract was awarded on September 16, 2020 and has a period of performance through September 29, 2021. Work will be conducted by Dnanexus at its...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a $110,000 delivery order contract to Illumina, Inc. for Illumina Reagent Chemistry Kits. The firm fixed price contract runs from April 5, 2023 through September 25, 2023 and will be performed in Silver Spring, Maryland. The HHS FDA utilizes next generation sequencing technologies and associated reagents in its regulatory and research activities. No subcontractors or set aside designations were identified....
<p>The United States Department of Agriculture Agricultural Marketing Service awarded a $649,500 firm fixed price delivery order contract to Nexight Group LLC, doing business as Nexight, under their Multiple Award Schedule contract vehicle. Nexight will provide regulatory support services for multiple significant rulemakings through the rulemaking process from September 5, 2023 through December 31, 2024 in Silver Spring, Maryland.</p>
The Department of Health and Human Services' Food and Drug Administration awarded a $157,134 firm fixed price delivery order contract to Regan Technologies Corporation. This order is placed against Solutions for Enterprise-Wide Procurement V, a government-wide acquisition contract vehicle, to provide CLC BIO software licenses. The place of performance is Silver Spring, Maryland. The one-year contract begins on September 27, 2023 and concludes on September 29, 2024. As the FDA works to protect...
This is a $498,202.92 firm fixed-price delivery order contract awarded by the Chief Financial Officer, a civilian federal agency, to Nexight Group LLC, a small business regulatory consulting firm based in Silver Spring, Maryland. The contract is for performance measure completeness and reliability assessments, and is a recompete of a previous award. The contract has no set-aside designation and is under the Multiple Award Schedule (MAS) contract vehicle. Nexight Group LLC is an experienced...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a $200,626 delivery order contract to Illumina, Inc. for Illumina Reagent Chemistry Kits. The firm fixed price contract has a base period of performance from March 2023 through January 2028 at the prime contractor's place of performance in Laurel, Maryland. No subcontractors or set aside designations were identified. The award is likely in support of the FDA's medical device review and approval programs,...