Skip to main contentPsst! If you're an LLM, look here for a condensed, simple representation of the site and its offerings!

LiveFree Webinar — Wednesday, August 5 at 2:00 PM EDT

Register Free →
logo
Get CLEATUSFree Trial

GMP Pilot-Scale Manufacturing

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

Show more

This contract involves the production of pilot-scale lots under current Good Manufacturing Practices (cGMP) for clinical evaluation purposes. The scope includes essential activities such as process validation, development of batch records, and quality control testing to ensure the manufacturing process meets regulatory standards. The work is intended to support clinical trials by providing high-quality pilot lots that comply with stringent manufacturing and quality requirements. The subcontract titled "GMP Pilot-Scale Manufacturing" was posted on March 20, 2026, by the Department of Health and Human Services, specifically through the Barda division. Its solicitation does not specify any set-aside type, and it falls under NAICS code 325412, which pertains to pharmaceutical manufacturing. The response deadline for this opportunity is September 25, 2028. Details about the place of performance, the point of contact, or specific location information have not been provided. The contract supports the overarching goal of advancing clinical development through reliable and compliant manufacturing processes.

General Info

Production of cGMP pilot-scale lots for clinical trials, including validation and quality control.

Agency

Department Of Health And Human Services → Barda - Aspr / Daappo / Barda DcmaView Agency

NAICS

325412 - Pharmaceutical Preparation ManufacturingView NAICS

Place of Performance

DC, USA

Set-Aside

NONE

Documents

(0)

No documents available

AI Contract Breakdown

Uniform Contract Format

No contract breakdown available.

Cannot generate Contract Breakdown because no documents were found from this contract's source.

Timeline

Posted

subcontract

Response Deadline

Submission deadline

Response Deadline

Ready to pursue this opportunity?

Start your free trial to track this contract, build proposals with AI assistance, and manage your pipeline.

Organization & Contact Information

Show more
AgencyDepartment Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

Show more
Production of pilot lots under cGMP for clinical evaluation, including process validation, batch record development, and quality control testing.

Similar Contracts

Same NAICS industry code

NAICS: 325412
New
DIBBS
ZINC OXIDE OINTMENTThe contract solicitation seeks zinc oxide ointment under NSN 6505-00-150-1990 with a requested quantity of five units, issued by the Defense Logistics Agency within the Department of Defense. The solicitation, identified by number SPE2DP-26-T-4279, was posted on July 26, 2026, and requires responses no later than August 3, 2026, with all deliveries expected to fulfill federal procurement requirements. No specific set-aside provisions or NAICS codes are designated, indicating open competition among qualified suppliers. The place of performance and point of contact details are not provided, and all further inquiries must be directed through the official DIBBS portal linked in the posting.
Defense Logistics Agency

POSTED

about 6 hours ago

DEADLINE

in 8 days
View Details
NAICS: 325412
New
SLED
Liquid Amies Transport Swab (ESWAB) SupplyThe contract is for the supply of ESWAB, Liquid Amies transport swabs with part number 480CFA, intended for the collection and transport of clinical specimens. This subcontract is issued under the Health and Human Services Commission in Texas and aligns with NAICS code 325412, indicating classification within pharmaceutical and medicine manufacturing. The solicitation was posted on July 24, 2026, with a response deadline set for August 18, 2026, at 4:30 PM. The swabs are critical for maintaining specimen integrity during transit and must meet specific clinical standards for accuracy and reliability. While the place of performance and point of contact details are not specified, the contract is accessible through the Texas SmartBuy portal for further procurement information.
Health and Human Services Commission

POSTED

2 days ago

DEADLINE

in 23 days
View Details
NAICS: 325412
New
Federal
Radiopharmaceutical Manufacturing and RadiosynthesisThe contract outlines the GMP-compliant manufacturing of critical radiopharmaceuticals including Ga-68 DOTATATE, FDG, and Tc-99m based agents, requiring strict adherence to quality control protocols and regulatory standards throughout all production phases. The work must be performed at a facility in New Orleans with a zip code of 70119 and must include robust emergency continuity plans to ensure uninterrupted supply, particularly for time-sensitive diagnostic agents. Production processes must meet all applicable FDA and nuclear regulatory requirements with full documentation and traceability from raw materials to final product release. This is a subcontract under the Department of Veterans Affairs 256-NETWORK Contract Office 16, with a solicitation response deadline of August 8, 2026, and a posted date of July 24, 2026. The North American Industry Classification System code 325412 indicates a focus on pharmaceutical preparation manufacturing. The successful offeror must demonstrate proven capability in radiopharmaceutical radiosynthesis, validated quality assurance systems, and capacity to handle the unique logistical and safety challenges of radioisotope production. Continuous operational readiness and compliance with nuclear safety and transportation regulations are essential requirements.
256-NETWORK Contract Office 16 (36C256)

POSTED

2 days ago

DEADLINE

in 13 days
View Details
NAICS: 325412
New
Federal
cDNA Clone & Molecular Biology SupplyThe contract pertains to the supply of cDNA clones encoding engineered antibody sequences for preclinical development, encompassing full molecular biology services from vector design through cloning and rigorous sequence validation. The work is required to deliver high-quality, accurately engineered genetic constructs that meet precise specifications for use in advancing therapeutic antibody candidates, ensuring reliability and reproducibility in downstream preclinical applications. All deliverables must be fully characterized and validated to confirm sequence fidelity and functional integrity. The solicitation, issued under the National Institutes of Health Office of Laboratory Animal Welfare within the Department of Health and Human Services, is a subcontract with a place of performance in Bethesda, Maryland, and carries the NAICS code 325412 for biological product manufacturing. Interested parties must submit responses by August 3, 2026, and the opportunity is open without specific set-aside classifications. The technical scope demands expertise in molecular cloning, antibody engineering, and quality control, with expectations for timely delivery and strict adherence to validated protocols to support rigorous preclinical timelines.
National Institutes Of Health Olao

POSTED

2 days ago

DEADLINE

in 8 days
View Details
NAICS: 325412
New
Federal
Reagents and Consumables Supply for Microbiology TestingThe contract entails the ongoing supply of FDA-approved reagents, culture media, and consumables specifically designed for use with a microbiological identification and antimicrobial susceptibility testing system. All provided materials must comply with strict shelf-life requirements to ensure reliability and accuracy in diagnostic testing, and the supplier is obligated to support emergency deliveries to maintain uninterrupted laboratory operations. The work is to be performed at a designated location in Palo Alto, California, with all goods meeting federal regulatory standards for clinical diagnostic use. The contract is structured as a subcontract under the Department of Veterans Affairs through the 261-NETWORK Contract Office 21, and the North American Industry Classification System code 325412 indicates that it falls under pharmaceutical and medicine manufacturing. Bids are due by July 31, 2026, with the opportunity publicly posted on July 24, 2026, allowing qualified vendors to respond within the seven-day window.
261-NETWORK Contract Office 21 (36C261)

POSTED

2 days ago

DEADLINE

in 5 days
View Details
NAICS: 325412
New
Federal
Radiopharmaceutical 5 yearThe U.S. Department of Veterans Affairs through the 256-NETWORK Contract Office 16 is conducting a sources sought synopsis to identify qualified vendors capable of providing radiopharmaceuticals to the Southeast Louisiana Veterans Health Care System in New Orleans, Louisiana. This is not a solicitation but a market research initiative to assess industry capabilities, business size classifications, and socioeconomic qualifications under NAICS code 325412, which has a size standard of 1,300 employees. Interested parties must submit a capability statement of five pages or less detailing their experience supplying radiopharmaceuticals to government or private medical facilities, including an authorized letter permitting such services. Responses must also include detailed information on business size, certification status under programs such as SDVOSB, VOSB, 8(a), HubZone, or woman-owned small business, UEI number, and SAM.gov registration status, with emphasis that future awards require active SAM registration and SBA certification for socioeconomic preferences. All submissions must be emailed to Veronica Maskell at veronica.maskell@va.gov with the subject line “Radiopharmaceuticals” no later than 2:00 PM CST on August 8, 2026. The response must not request a solicitation, as none currently exists; any future contract opportunity will be separately announced on GSA eBUY or Contract Opportunities, and vendors must respond to that formal solicitation to be considered for award. The Government will use responses to inform acquisition strategy and determine whether to proceed with a formal procurement. Proprietary information submitted will be protected in accordance with FAR 15.201(e), and respondents bear all costs associated with their submission. The place of performance is specified as New Orleans, LA, and the contract office is based in Ridgeland, MS, with the posting dated July 24, 2026. Failure to provide all requested information may result in the response being deemed inadequate for planning purposes.
256-NETWORK Contract Office 16 (36C256)

POSTED

2 days ago

DEADLINE

in 13 days
View Details
NAICS: 325412
New
DIBBS
Chemical Agent Detector Refill Kit ManufacturingThe contract pertains to the manufacture of reactive chemical refill kits designed for use in military chemical agent detectors, encompassing the full scope of formulation, assembly, and packaging processes under strict hazardous material regulations. The work must adhere to established safety and compliance standards applicable to the handling and processing of chemically reactive substances, ensuring the kits are both effective and safe for deployment in military operations. The production environment must be certified and controlled to prevent contamination and to meet government-mandated protocols for hazardous goods. The subcontract is issued under the NAICS code 325412, indicating a focus on pharmaceutical and chemical manufacturing, and is managed by the Electrical Devices Division within the Department of Defense. Performance is required at an FPO address with ZIP code 96683, suggesting logistical coordination across military or overseas locations. The solicitation was posted on July 23, 2026, with proposals due by August 3, 2026, allowing a limited window for qualified vendors to respond. The contract does not specify a set-aside classification, and no point of contact information is provided in the solicitation, requiring potential bidders to navigate the DIBBS platform directly for further details.
ELECTRICAL DEVICES DIV

POSTED

3 days ago

DEADLINE

in 8 days
View Details
NAICS: 325412
New
DIBBS
TEST STRIPS AND COLORThe contract specifies the procurement of urine test strips and color charts capable of detecting bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen, each packaged in bottles of 100 strips per unit, with a total quantity of two units required. The items must comply with stringent technical and quality requirements referenced from the DLA Master List of Technical and Quality Requirements and are subject to medical packaging standards, including compliance with Medical Marking Standard No. 1, which supersedes MIL-STD-129. Packaging must ensure protection against damage and safe delivery via common carriers at the lowest cost, with all labels clearly displaying the date of manufacture, expiration date, contract number, and lot number in accordance with MMS1C guidelines. A shelf-life requirement of 18 months is mandatory and non-extendable, with no more than two months allowed to have elapsed between the date of manufacture and the date of delivery to the government. The items are classified as a TYPE I (CODE K) item under the shelf-life specification, and all labeling must conform to the latest revision of MMS1C. The solicitation number is SPE2DS-26-T-263E, issued on July 23, 2026, with responses due by July 29, 2026, and delivery required within five days of award. The contracting office is under the Department of Defense’s Medical Supply Chain, with Mary-Kathryn Donahue designated as the primary point of contact. The NSN is 6550-01-221-5400, and the NAICS code is 325412, identifying the industry as medical and surgical instrument manufacturing.
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

3 days ago

DEADLINE

in 3 days
View Details
NAICS: 325412
New
DIBBS
ERYTHROMYCIN OPHTHALMIErythromycin Ophthalmic Ointment, USP, is a sterile topical medication containing 5 mg of erythromycin per gram in a base of mineral oil and white petrolatum, formulated for ophthalmic use as an RX-only product. Each unit is packaged in single-dose tubes containing 3.5 grams of ointment, with a unit of issue consisting of 24 tubes per package. The product has a total shelf life of 36 months, and upon receipt by the first government activity, it must have a minimum of 31 months of remaining shelf life. Storage requirements specify controlled room temperature between 15°C and 30°C (59°F–86°F), with protection from excessive heat and freezing. All packaging and labeling must strictly conform to Medical Marking Standard No. 1, superseding MIL-STD-129, and commercial packaging must comply with ASTM D3951 unless overridden by DLA’s Master List of Technical and Quality Requirements. The manufacturer is PADAGIS US LLC with NDC 00574-4024-39, and the NSN is 6505-01-189-7090. The contract requires delivery of one package (24 tubes) to Fort Bragg, North Carolina, within 20 days of issuance, with FOB destination and zero tolerance for quantity variance. Delivery must be made via traceable freight methods, excluding parcel post, and packaging must meet all DLA procurement standards including palletization and hazardous material handling per FED-STD-313 where applicable. The item falls under a Type I (Code Q) shelf-life category with a non-extendable 36-month lifespan. The contracting official must submit a referral via EBS to confirm product compliance with FDA regulations, including manufacturer and part number details. The solicitation, issued under SPE2DP-26-T-4260, was posted on July 23, 2026, with a response deadline of July 29, 2026, and the required delivery date is July 14, 2026. All documentation, labeling, and marking must align with DLA’s current technical and quality requirements, and the point of contact for inquiries is James McCullough.
MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

3 days ago

DEADLINE

in 3 days
View Details
NAICS: 325412
New
DIBBS
LORATADINE TABLETSLoratadine tablets 10 mg are being procured in quantities of 2 business units, with each unit containing 500 tablets, for a total of 1,000 tablets under contract SPE2DP-26-T-4248. The product must comply with all technical and quality requirements referenced in the DLA Master List of Technical and Quality Requirements, including packaging and marking standards specified in Medical Marking Standard No. 1, which replaces MIL-STD-129. Packaging must be commercial-grade, with each unit sealed in a container that protects against damage and breakage, and shipped in exterior containers suitable for safe delivery via common carrier at the lowest cost to the destination point. The item is regulated by the FDA and requires storage between 20°C and 25°C (68°F to 77°F), protected from excessive moisture. It has a non-extendable shelf life of 36 months, classified as a TYPE I (CODE Q) item under DLA shelf-life requirements. The manufacturer is OHM Laboratories Inc. with NDC 51660-0526-05, and the distributor is AmerisourceBergen Drug Corp. Delivery is FOB destination within 20 days of contract award with zero tolerance for quantity variance, and inspection and acceptance occur at the delivery point. The NSN is 6505-01-524-9179, and all markings must adhere to the latest MMS No. 1 guidelines available through DLA Troop Support. The contracting official must submit a referral in EBS with manufacturer and bidder details prior to award.
MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

3 days ago

DEADLINE

in 3 days
View Details
NAICS: 325412
New
DIBBS
DEXAMETHASONE TABLETSThe contract pertains to the procurement of Dexamethasone Tablets, USP, 0.5 mg, in unit dose packaging under the National Stock Number 6505-01-045-0451, with a total quantity of 2 packaging groups, each equivalent to 100 tablets. The supplier must adhere to strict packaging and labeling requirements as defined by Medical Marking Standard No. 1, which supersedes MIL-STD-129, and all units must be sealed in protective containers to ensure integrity during shipment. The product, manufactured by Roxane Labs or Hikma Pharmaceuticals USA Inc. under NDC 00054-8179-25, is regulated by the FDA and requires confirmation via EBS referral. It carries a non-extendable shelf life of 36 months and must be marked in full compliance with the latest Medical Marking Standard. Delivery is required FOB destination within five days of contract award, with zero variance allowed in quantity, and inspection and acceptance occur at the destination point. The solicitation is issued under SPE2DP-26-T-4266, with a response deadline of July 29, 2026, and the sole point of contact is James Foggie at DLA Troop Support, with performance directed to Fort Bragg, NC, 28310.
MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

3 days ago

DEADLINE

in 3 days
View Details
NAICS: 325412
New
DIBBS
TUBE, EXTENSION, INJEThe item is a 3-way stopcock extension set with 60-inch small bore tubing featuring a male luer lock connection, designed for injection procedures, with a priming volume of 1.3 mL and packaged in quantities of 25 units per package. The product is identified by NSN 6515-01-550-8492 and is being procured under solicitation SPE2DS-26-T-268C, with a response deadline of July 29, 2026, and a delivery requirement of 20 days after award. The specification includes technical and quality requirements referenced in the DLA Master List, and packaging must comply with DLA standards, including the removal of government identification from non-accepted supplies. The contract is managed by the Department of Defense through the Medical Supply Chain MD Surg FSF office, with performance required at Fort Bliss, Texas, and point of contact information provided for inquiries.
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

3 days ago

DEADLINE

in 3 days
View Details

More opportunities from Department Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma

Same awarding agency

NAICS: 541714
Federal
RFP - 2-PAM Autoinjectors for Project Bioshield (PBS)The Biomedical Advanced Research and Development Authority (BARDA) is seeking proposals under solicitation 75A50126R00002 to develop, obtain regulatory approval for, and procure approximately two million 2-PAM (600mg) autoinjectors as a drug/device combination product for the treatment of organophosphate poisoning, including nerve agents, in both adult and pediatric populations. This effort supports the Strategic National Stockpile (SNS) and CHEMPACK Program. The contract is structured as a hybrid cost-plus-fixed-fee and firm-fixed-price instrument with an anticipated base performance period of up to 36 months and potential extension through options to a total duration of eight years. Key deliverables include late-stage clinical development, regulatory submission and approval, and large-scale manufacturing of autoinjectors, with production split across multiple CLINs totaling 2 million units. The solicitation is issued as a Statement of Objectives, requiring offerors to submit a comprehensive Statement of Work and Risk Mitigation Plan addressing program management, product development, supply chain logistics, and optional post-marketing commitments. Manufacturing and packaging must adhere to Good Manufacturing Practice regulations under 21 CFR Part 820, and all products must maintain strict temperature controls during transit, with ambient exposure logging required from the offeror’s validated facility until acceptance by the government at the ASPR/SNS location in Washington, D.C. All proposals must comply with mandatory eligibility criteria, including adherence to FAR and HHSAR clauses covering cost allowability, inspection, intellectual property, anti-kickback, and contingency fee restrictions. Offerors are required to complete SAM.gov representations and certifications, submit a detailed organizational chart identifying key personnel including a Program Director, Chief Scientific/Medical Officer, Manufacturing Lead, Regulatory Affairs Lead, and Project Manager, and demonstrate compliance with human subject protections under 45 CFR 46. Security requirements mandate layered physical controls, identification verification for personnel and visitors, and robust information and cyber security protocols encompassing access controls, intrusion detection, and encryption. Proposals must be submitted by July 30, 2026, and remain firm for 120 days. Evaluation will prioritize technical merit, past performance, and overall value over cost, with non-cost factors carrying significantly greater weight. Contract administration requires electronic invoice submissions via the Treasury IPP system to designated federal offices and strict adherence to documentation handling, packaging, and delivery protocols. The procurement is open to all qualified entities without set-aside restrictions
Research and Development in Biotechnology (except Nanobiotechnology)

POSTED

18 days ago

DEADLINE

in 4 days
View Details
NAICS: 484220
Federal
Logistics and Distribution to SNS/CHEMPACKsThe contract encompasses the temperature-controlled logistics and distribution of finished autoinjectors to SNS and CHEMPACK sites, ensuring product integrity through strict thermal monitoring using TempTale devices throughout transit. All shipments must include comprehensive documentation of ambient exposure conditions to verify compliance with required temperature thresholds, with real-time and post-delivery data submission mandated to maintain accountability and regulatory adherence. The operation demands precision in handling, transport, and chain-of-custody procedures to safeguard the efficacy of medical countermeasures destined for federal emergency response stockpiles. Performance is centered at Washington DC with a 20024 ZIP code as the designated point of performance, and the contract falls under NAICS code 484220 for specialized truck transportation. It is structured as a subcontract under the Department of Health and Human Services via Barda-ASPR/DAAPPO, with responses due by July 30, 2026. The requirement emphasizes end-to-end control of environmental conditions, documentation rigor, and reliability in delivery to support national preparedness objectives, with no set-aside provisions indicated. All parties must adhere to federal standards for medical logistics without exception.
Specialized Freight (except Used Goods) Trucking, Local

POSTED

24 days ago

DEADLINE

in 4 days
View Details
NAICS: 325998
Federal
Packaging, Labeling, and Serialization ServicesThe contract outlines the final packaging, labeling, and serialization of autoinjectors to meet FDA compliance standards, including the implementation of Unique Device Identification (UDI) and cold chain compatibility to ensure product integrity throughout distribution. All labeling must adhere to federal regulatory requirements, with precise serialization to enable traceability and enhance patient safety across the supply chain. The work involves precision handling and documentation protocols tailored for sensitive pharmaceutical devices requiring temperature-controlled environments. This subcontract is issued under the NAICS code 325998 and is associated with the Department of Health and Human Services through Barda - Aspr / Daappo / Barda Dcma, with performance centered in Washington, DC 20024. The opportunity was posted on July 2, 2026, and responses are due by July 30, 2026. While the solicitation number and set aside details are unspecified, the contract emphasizes compliance, quality control, and regulatory adherence critical to the delivery of approved medical devices to U.S. markets.
All Other Miscellaneous Chemical Product and Preparation Manufacturing

POSTED

24 days ago

DEADLINE

in 4 days
View Details
NAICS: 541380
Federal
Environmental and Stability Testing ServicesBarda - Aspr / Daappo / Barda Dcma, under the Department of Health and Human Services, is seeking a subcontractor to perform environmental and stability testing services in accordance with ICH guidelines to validate the shelf-life and storage conditions of pharmaceutical products. The work involves conducting laboratory-based stability studies and environmental stress tests to ensure product integrity under various temperature, humidity, and light conditions as required by international regulatory standards. Performance is expected to occur in Washington, DC, with a response deadline of July 30, 2026, and the solicitation was posted on July 2, 2026. The contract falls under NAICS code 541380, which categorizes it as other scientific and technical consulting services, and it is not set aside for any specific small business category. All testing must be executed with strict adherence to ICH compliance to support regulatory submissions and product approval processes.
Testing Laboratories and Services

POSTED

24 days ago

DEADLINE

in 4 days
View Details
NAICS: 325412
Federal
Consistency Lot and PPQ Manufacturing SupportThe contract titled Consistency Lot and PPQ Manufacturing Support is a subcontract aimed at producing consistency and process validation batches to ensure full compliance with current good manufacturing practices and to maintain regulatory readiness. The work is scheduled to support critical pharmaceutical manufacturing activities under the oversight of the Department of Health and Human Services through its agency Barda - Aspr / Daappo / Barda Dcma, with the primary place of performance located in Washington, DC, specifically at the zip code 20024. The North American Industry Classification System code 325412 indicates the scope involves pharmaceutical and botanical product manufacturing, underscoring the technical and regulatory rigor required for the deliverables. Interested parties must submit proposals by the response deadline of July 30, 2026, at 9:00 PM ET, following a solicitation posted on July 2, 2026. There is no set-aside designation specified, meaning the opportunity is open to all eligible contractors without preference based on business size or type. The contract is focused on delivering validated manufacturing outputs that meet strict quality benchmarks to support product approval and ongoing regulatory submissions, requiring the contractor to possess proven expertise in process validation, batch documentation, and adherence to cGMP standards throughout all phases of production.
Pharmaceutical Preparation Manufacturing

POSTED

24 days ago

DEADLINE

in 4 days
View Details
NAICS: 541611
Federal
Program Management and Regulatory AffairsThe contract entails comprehensive program management and regulatory affairs support for a drug-device combination product, focusing on end-to-end oversight of critical development and compliance activities. This includes managing regulatory submissions to health authorities, conducting human factors studies to ensure safe and effective user interaction, validating process performance qualification (PPQ) batches to confirm manufacturing consistency, and fulfilling all post-market licensing commitments required by regulatory agencies. The scope demands deep expertise in both pharmaceutical and medical device regulations, with an integrated approach to aligning clinical, quality, and technical documentation across global standards. The work is governed under a subcontract agreement linked to the Department of Health and Human Services via Barda - Aspr / Daappo / Barda Dcma, with performance centered in Washington, DC, at ZIP code 20024. The solicitation was posted on July 2, 2026, and responses are due by July 30, 2026, under the NAICS code 541611 for management consulting services. The contractor is expected to deliver coordinated, high-quality regulatory strategy and execution in a tightly regulated environment, ensuring timely approvals and sustained compliance throughout the product lifecycle.
Administrative Management and General Management Consulting Services

POSTED

24 days ago

DEADLINE

in 4 days
View Details
NAICS: 325412
Federal
Adult Dose Autoinjector Device ManufacturingThe contract entails the full-scale manufacturing of 1.5 million adult-dose autoinjector devices under firm-fixed-price terms, with strict requirements for temperature-controlled production processes and comprehensive stability assurance throughout the lifecycle of the devices. The work must be performed to ensure product integrity and regulatory compliance, with all phases of manufacturing conducted under controlled environmental conditions to maintain clinical efficacy and safety standards. The production timeline is tied to a firm deadline, with responses due by July 30, 2026, following the solicitation’s public posting on July 2, 2026. This subcontract falls under NAICS code 325412, indicating pharmaceutical and medicinal product manufacturing, and is managed by the Department of Health and Human Services through Barda - ASPR / DAAPPO / Barda DCMA. The place of performance is designated as Washington, D.C., with a zip code of 20024, suggesting that key logistical, oversight, or final assembly activities must occur in or near the federal capital. No set-aside provisions are specified, and the contract is intended for full competition among qualified manufacturers capable of meeting rigorous quality, volume, and environmental standards required for high-volume pharmaceutical device production.
Pharmaceutical Preparation Manufacturing

POSTED

24 days ago

DEADLINE

in 4 days
View Details
NAICS: 541715
Federal
Animal Model Development for Phosphine & Cyanide ExposureThis contract involves the development and validation of animal models designed to accurately replicate human exposure to phosphine and cyanide. These models are intended to be used for testing medical countermeasures under the FDA Animal Rule, which provides regulatory pathways for drugs and biologics when human trials are not ethical or feasible. The work falls under the subcontract category and is associated with the Department of Health and Human Services, specifically managed by BARDA (Biomedical Advanced Research and Development Authority) and affiliated offices. The focus of the effort is to create reliable and scientifically robust animal models that can simulate the toxicological and pharmacological effects of phosphine and cyanide exposure in humans. This will facilitate the evaluation and approval of medical treatments aimed at counteracting these toxic agents in emergency or threat scenarios. The contract aligns with NAICS code 541715, which involves research and development in the physical, engineering, and life sciences sectors. The solicitation was posted in April 2026, and although specific details on location and points of contact are not provided, the contract is accessible through official government procurement platforms.
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

3 months ago

DEADLINE

N/A
View Details
NAICS: 541620
Federal
Expanded Biological Sample Analysis (Toxicology & Biomarkers)The contract involves the comprehensive analysis of biological samples, including blood, serum, and urine, to identify toxicological markers, conduct metabolomic profiling, and gather pharmacokinetic data. This work is aimed at assessing the safety and efficacy of medical countermeasures (MCM), supporting efforts to ensure that these interventions meet required safety standards and perform effectively in relevant scenarios. The contract falls under the NAICS code 541620, which relates to environmental consulting services, indicating specialized scientific and analytical work. Awarded by the Department of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA), the subcontract focuses on advanced biological sample analysis as part of ongoing health protection initiatives. Although specific solicitation and contact details are not provided, the contract was posted in April 2026 and is intended to bolster toxicological and biomarker research critical to public health preparedness and response efforts. The work is conducted under the oversight of BARDA programs, underscoring its strategic importance in developing therapeutic and diagnostic solutions.
Environmental Consulting Services

POSTED

3 months ago

DEADLINE

N/A
View Details
NAICS: 541380
Federal
In Vivo Imaging and Data Acquisition (Preclinical)This contract involves conducting in vivo preclinical imaging using modalities such as MRI, CT, and PET to study live animal models during nonclinical investigations. The goal is to evaluate physiological responses to various chemical agents and medical countermeasures, supporting the assessment and development of these substances. The contract is issued as a subcontract under the NAICS code 541380 and is managed by the Department of Health and Human Services through its bureaus including BARDA and ASPR. The contract emphasizes data acquisition and analysis in preclinical settings, playing a critical role in advancing medical research and product development aimed at improving public health preparedness and response. The location details and point of contact information were not specified, but the contract was posted on April 22, 2026, reflecting ongoing efforts to support nonclinical study capabilities in biomedical research.
Testing Laboratories and Services

POSTED

3 months ago

DEADLINE

N/A
View Details
NAICS: 541611
Federal
Tissue Collection, Processing, and HistopathologyThis contract involves the collection, preservation, sectioning, and histological analysis of animal tissues following exposure to chemical agents and medical countermeasures (MCMs). The purpose is to support toxicology and efficacy assessments, ensuring thorough examination of tissue responses to these substances. The scope includes detailed processing and microscopic evaluation to provide critical data for understanding the biological effects and safety profiles of the tested agents. Issued by the Department of Health and Human Services under the BARDA-ASPR/DAAPO/BARDA DCMA umbrella, this subcontract falls under the NAICS code 541611, indicating professional, scientific, and technical services. The contract was posted on April 22, 2026, and although specific location details and points of contact are not provided, it is structured to facilitate specialized laboratory analysis essential for public health preparedness and response initiatives.
Administrative Management and General Management Consulting Services

POSTED

3 months ago

DEADLINE

N/A
View Details
NAICS: 541714
Federal
Nonclinical Animal Dose Escalation Studies (Schedule 1 Chemicals)This contract involves the execution of nonclinical dose escalation studies using highly hazardous chemical agents, such as phosphine and cyanide, in animal models. The primary goal is to evaluate the efficacy of medical countermeasures under the FDA’s Animal Rule, which allows for drug approval based on animal testing when human trials are not ethical or feasible. The work focuses on Schedule 1 chemicals, requiring strict adherence to safety and regulatory standards due to the high-risk nature of the substances involved. The contract is a subcontract under the Department of Health and Human Services, specifically managed by the Biomedical Advanced Research and Development Authority (BARDA) along with associated offices. It falls under the NAICS code 541714, which covers research and development in biotechnology. While specific details about the location of performance and points of contact are not provided, the contract supports the development of critical medical countermeasures aimed at protecting public health from chemical threats.
Research and Development in Biotechnology (except Nanobiotechnology)

POSTED

3 months ago

DEADLINE

N/A
View Details