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Shionogi, Inc

UEI: SLED_0D7E14731A0F06C3

Shionogi, Inc is a federal contractor, registered under UEI SLED_0D7E14731A0F06C3. It has been awarded $481,678,300 across 1 federal contract. Primary work spans Unknown NAICS. Top awarding agencies include Barda - Aspr / Daappo / Barda Dcma.

Contact Information

Registration and classification details

Registration

UEI Code

SLED_0D7E14731A0F06C3

Federal Contracting Overview

Award totals, agency breakdown, NAICS distribution, and geographic footprint.

Key Performance Metrics

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Award Analytics & Distribution

Awards by Agency

Barda - Aspr / Daappo / Barda Dcma$481.7M100%

Awards by NAICS

- Unknown NAICS$481.7M100%

Awards by Agency Over Time

Awards by Place of Performance

Open opportunities in Shionogi, Inc's top NAICS codes and agencies

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

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

Specialized Compliance and Safety ConsultingThis contract involves providing specialized compliance and safety consulting services focused on supporting the use of Select Agents, ensuring adherence to human subjects research protocols under the Institutional Review Board (IRB), maintaining proper animal care standards through the Institutional Animal Care and Use Committee (IACUC), and managing export control compliance. The work falls under NAICS code 541690, indicating professional scientific and technical consulting services, and is structured as a subcontract. The contract is issued by the Department of Health and Human Services, specifically through the Barda - Aspr / Daappo / Barda Dcma office, reflecting its connection to public health and advanced research initiatives. The solicitation was posted in March 2026, with a response deadline set for September 2028, signaling a long-term project timeline. While specific geographic details and points of contact are not provided, the focus on compliance across several critical regulatory areas highlights the importance of expert advisory support to maintain legal and ethical standards in research and safety operations.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

in about 2 years

Project and Program Management SupportThis contract entails providing project and program management support focused on milestone tracking, go/no-go decision reviews, risk assessment, and facilitating coordination between technical teams and the Biomedical Advanced Research and Development Authority (BARDA). The services will ensure effective oversight and management of project progress and risks, helping to align technical deliverables with BARDA's requirements. The contract is a subcontract under the NAICS code 541690, indicating professional and management development consulting services. It was posted on March 20, 2026, with a response deadline of September 25, 2028. The contracting agency is the Department of Health and Human Services, specifically BARDA under the Office of the Assistant Secretary for Preparedness and Response. Although geographic specifics for performance and point of contact details are not provided, the primary engagement is aimed at supporting BARDA’s mission through enhanced project and risk management processes.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

in about 2 years

Regulatory Affairs and Submissions SupportThis contract involves providing comprehensive regulatory affairs and submissions support, specifically focused on preparing and submitting documentation to the FDA. Key tasks include handling Investigational New Drug (IND) and Investigational Medicinal Product Dossier (IMPD) applications, supporting Biologics License Applications (BLA), and responding to inquiries from regulatory agencies. The contract is structured as a subcontract under the NAICS code 541611, which pertains to administrative management and general management consulting services. Issued by the Department of Health and Human Services through the Barda - Aspr / Daappo / Barda Dcma office, the solicitation was posted on March 20, 2026, and responses are due by September 25, 2028. While specific location details and points of contact are not provided, the work is intended to support regulatory compliance efforts essential for advancing medical and biopharmaceutical developments through FDA oversight. This contract is crucial for ensuring that regulatory submissions are accurately prepared and timely, facilitating smooth interactions with the agency.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

in about 2 years

Analytical and Stability Testing ServicesThis contract involves providing analytical and stability testing services focused on pharmaceutical or related products. The work includes conducting real-time and accelerated stability studies, developing and validating analytical methods, and characterizing products using advanced techniques such as high-performance liquid chromatography (HPLC) and mass spectrometry. These tasks are essential for ensuring product quality, efficacy, and regulatory compliance. The contract is a subcontract issued by the Department of Health and Human Services, specifically under the BARDA (Biomedical Advanced Research and Development Authority) and related divisions. It falls under the NAICS code 541380, which covers testing laboratories and analytical services. The solicitation was posted on March 20, 2026, with a response deadline set for September 25, 2028, indicating a lengthy period for proposal submission. The place of performance and specific organizational types are not specified, but the contract supports efforts within health and human services sectors, reflecting its importance in public health preparedness and pharmaceutical development.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

in about 2 years

Clinical Trial Design and ManagementThis contract involves the development and management of clinical trial protocols, including support for Investigational New Drug (IND) applications and Risk Evaluation and Mitigation Strategies (REMS) proposals. It also encompasses coordination with clinical sites to ensure regulatory compliance and effective execution of clinical trials. The work falls under the NAICS code 541611, which pertains to administrative management and general management consulting services, indicating a focus on specialized professional services in clinical trial oversight. Issued by the Department of Health and Human Services through the BARDA offices, this subcontract was posted on March 20, 2026, with a response deadline extending to September 25, 2028. While specifics on the place of performance and point of contact are not provided, the contract emphasizes regulatory alignment and operational coordination to support clinical research activities, aimed at facilitating successful trial design and implementation in line with federal health regulations.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

in about 2 years

GMP Pilot-Scale ManufacturingThis 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.

Barda - Aspr / Daappo / Barda Dcma

POSTED

DEADLINE

in about 2 years