The FDA has awarded Eurofins Panlabs, Inc., a foreign-owned for-profit contract research organization, a single-award indefinite delivery contract (IDC) worth up to $20 million for research and development services and studies through September 2028. Under this IDC, Eurofins Panlabs provides non-clinical and laboratory support services such as analytical chemistry, microbiology, and toxicology testing to support the discovery and development of drug candidates. This includes evaluating the...
The Department of Health and Human Services Food and Drug Administration awarded an indefinite delivery contract to We Pharma, Inc., doing business as WEP Clinical, with a potential value of $9.5 million. The contract has no set-aside designation and is a single-award arrangement to provide currently marketed drug products for FDA research studies from September 2020 through September 2025. Under this contract, WEP Clinical has received multiple firm fixed price delivery orders to supply...
The Department of Health and Human Services' National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) has awarded a single-award indefinite delivery contract to Polypeptide Laboratories San Diego, LLC, a Contract Development & Manufacturing Organization (CDMO), to provide chemistry, manufacturing, and controls (CMC) services for the development of drug substances. This five-year, $49.7 million IDV contract, awarded without set-asides, supports NCATS'...
Altasciences Clinical Kansas Inc. was awarded a single-award indefinite delivery contract from the Department of Health and Human Services Food and Drug Administration valued at up to $5 million. The contract aims to advance generic drug approvals through the conduct of bioequivalence studies and characterization of generic drugs. Three firm fixed price delivery orders have been issued against this contract to date, with places of performance in Overland Park, Kansas. The first delivery order,...
This is an indefinite-delivery/indefinite-quantity (IDIQ) contract awarded by the Department of Health and Human Services' National Institutes of Health National Center for Advancing Translational Sciences (NCATS) to Bachem Americas, Inc., a foreign-owned, for-profit manufacturer of pharmaceutical ingredients. The contract, valued up to $49.7M, is for Chemistry, Manufacturing, and Controls (CMC) services to support NCATS' drug development programs, including the production of active...
This $49.9 million Indefinite Delivery Contract was awarded by the National Institute on Drug Abuse (NIDA), a civilian agency, to PPD Development LP, a global contract research organization (CRO) subsidiary of Thermo Fisher Scientific. The contract is for research and development related to clinical studies under NIDA's Blueprint MedTech program, which focuses on medical technology development for nervous system disorders. Under this IDC, PPD will provide a range of services including developing...
The Department of Health and Human Services National Institutes of Health (NIH) Clinical Center has awarded a $6 million, single-award Indefinite Delivery Contract (IDC) to Central Admixture Pharmacy Services Inc. (Caps) for the provision of 503A compounded sterile preparations and parenteral nutrition solutions. Caps is a for-profit organization that operates as both a 503A traditional pharmacy and a 503B outsourcing facility, specializing in customized intravenous mixtures, sterile admixtures,...
The National Institutes of Health's National Institute of Child Health and Human Development awarded an indefinite delivery contract to The Regents of the University of California, San Francisco to conduct clinical trials in support of contraceptive development. With a potential value of $5 million and a period of performance through July 2027, this multiple-award contract enables the agency to issue task orders for phase I-IV contraceptive trials in women and treatment trials for gynecologic...
The Department of Health and Human Services' National Center for Advancing Translational Sciences (NCATS) has issued a multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) contract valued at up to $49,885,703 to support Chemistry, Manufacturing, and Control (CMC) services for drug product development. The 7-year contract was awarded to Fisher Bioservices Inc.'s Clinical Trials Division, a subsidiary of Thermo Electron Corporation. The contract scope includes a wide range of CMC services...
This indefinite delivery contract awarded by the National Institute on Drug Abuse (NIDA), a civilian federal agency, to PPD Development LP, a global contract research organization (CRO) subsidiary of Thermo Fisher Scientific, provides regulatory consulting assistance and research and development support for medical device development projects under the Blueprint MedTech (BPMT) program. The contract has a ceiling value of $24 million over a 5-year ordering period from September 2022 to...