Definitive Contract 75F40124C00055
- Not listed
- This is a direct 8(a) sole-source contract award from the Food and Drug Administration (FDA) to Kaiva Strategies, LLC, a tribally-owned, minority-owned small business based in Ivins, Utah. The 1-year base period contract, with two 1-year option periods, is for $752,623.09 and provides professional services support to the FDA's Center for Drug Evaluation and Research (CDER). The contract is a labor-hour, stand-alone agreement for services such as medical writing, scientific writing, editing,...
- The Food and Drug Administration awarded a direct 8(a) sole source contract to Kaiva Strategies, LLC, a tribally-owned, minority-owned small business based in Ivins, Utah, on August 27, 2024. The contract is structured as a Time and Materials engagement with a ceiling value of approximately $3.1 million, consisting of one 12-month base period and four optional 12-month periods, with ultimate completion scheduled for April 25, 2029. The contract will be performed in Silver Spring, Maryland, and...
- The U.S. Food and Drug Administration (FDA) has awarded a single, labor-hour type contract to Kaiva Strategies, LLC, a tribally-owned, minority-owned small business, for project management support services. This is an 8(a) sole source contract with a 12-month base period and no option periods. The contract has a ceiling value of $1,686,696.40. Kaiva Strategies, LLC is certified as an 8(a) joint venture and holds additional small business certifications, including HUBZone and small...
- The U.S. Food and Drug Administration awarded a direct 8(a) sole source contract modification to Kaiva Strategies, LLC, a tribally-owned, minority-owned small business headquartered in Ivins, Utah. The modification reduces the level of effort for Option Period 1 and exercises that option period through August 25, 2029. The contract, valued at approximately $896,500, is a time-and-materials definitive contract that provides subject matter expert and technical expert strategic planning services to...
- This is a 1-year, labor-hour type contract awarded by the U.S. Food and Drug Administration (FDA) to Kaiva Strategies, LLC, a tribally-owned, minority-owned small business. The contract is for $359,086.60 and provides regulatory support for the FDA's Generic Drug Program, including research and documentation to support the review of Abbreviated New Drug Applications. The contract is a direct 8(a) sole source award, leveraging Kaiva Strategies' 8(a) certification from the Small Business...
- This is a $470,227.14, firm fixed-price definitive contract awarded by the Food and Drug Administration (FDA) to Kaiva Strategies, LLC, a tribally-owned, minority-owned small business. The contract is to provide services to support the FDA's Center for Food Safety and Applied Nutrition (CFSAN) scientific messaging. The contract is an 8(a) sole source award with an ultimate completion date of August 21, 2028. Kaiva Strategies is a small business with multiple certifications, including 8(a)...
- This is a $93,839.40 purchase order contract awarded by the Food and Drug Administration (FDA) to Kaiva Strategies, LLC, a tribally-owned, minority-owned small business headquartered in Ivins, Utah. The contract is for CFSAN OFS DPS Technical Expert Support Services and is set aside for 8(a) sole source. Kaiva Strategies is providing technical expert support services to the FDA's Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Safety (OFS), and Division of Produce Safety...
- This is a 3-year, labor-hour type contract awarded by the Food and Drug Administration (FDA) to Kaiva Strategies, LLC, a tribally-owned, minority-owned small business, to provide technical support for the FDA's Office of Food Additive Safety (OFAS)/Division of Science and Technology. The contract is a direct 8(a) sole source award with a ceiling value of $653,425.94. Kaiva Strategies, LLC is a certified 8(a) Joint Venture and holds several other small business certifications, which have...
- The Food and Drug Administration (FDA) awarded a $9,594,482 labor hour contract to Kaiva Strategies, LLC, an 8(a) certified small business, to provide writer/editor support services to the Center for Drug Evaluation and Research (CDER) and Office of New Drugs (OND). The contract has an ultimate completion date of June 24, 2025 and was issued a notice to proceed on May 30. Kaiva Strategies is a tribally-owned, minority-owned small business based in Ivins, Utah that specializes in providing...
- The Food and Drug Administration awarded a $1.95 million definitive contract to Kaiva Strategies, LLC, a tribally-owned, minority-owned small business based in Ivins, Utah, on May 6, 2024. Under this 8(a) sole source set-aside contract, Kaiva will provide subject matter expert (SME IX-level) professional support services to the Center for Drug Evaluation and Research's Office of the Center Director and the Center for Veterinary Medicine. The scope includes regulatory support related to the...
This is a bilateral modification to a definitive Time and Materials contract awarded by the Food and Drug Administration (FDA) to Kaiva Strategies, LLC, a tribally-owned, minority-owned small business based in Ivins, Utah. The contract, valued at $3,297,141.64, is an 8(a) sole source award for professional and technical support services to be performed in Silver Spring, Maryland. Kaiva Strategies holds multiple small business certifications, including 8(a) joint venture, HUBZone, small disadvantaged business, and minority-owned business status. The contract supports the FDA's Center for Drug Evaluation and Research, Center for Food Safety and Applied Nutrition, Office of Vaccines Research and Review, and Office of Tissues and Advanced Therapies through services such as medical writing, scientific communication, regulatory support, and program management. Kaiva Strategies also holds two significant Indefinite Delivery Contracts with the FDA, valued at $100 million and $22 million, providing flexible mechanisms for the agency to obtain the company's specialized expertise across various program offices.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00005 | Supplemental Agreement for work within scope | $595.3k | 9/25/25 | |
| P00004 | Supplemental Agreement for work within scope | $1.0m | 8/26/25 | |
| P00003 | Other Administrative Action | $0 | 8/18/25 | |
| P00002 | Other Administrative Action | $0 | 6/11/25 | |
| P00001 | Supplemental Agreement for work within scope | $188.9k | 11/7/24 |