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 19 at 2:00 PM EDT

Register Free →

Pharmaceutical Supply and Dosing Strategy Support

Active
Federal

Contract Overview

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

AI Contract Overview

Show more

The contract pertains to the formulation, stability testing, and supply chain management of ibogaine or closely related compounds under an Investigational New Drug application to support clinical research initiatives. It requires the secure and compliant production of precise dosing formulations, adherence to rigorous pharmaceutical standards for compound stability, and robust logistics to ensure uninterrupted delivery of materials to authorized research sites. All activities must align with federal regulatory requirements governing investigational substances and be executed within a tightly controlled framework to maintain quality, safety, and chain-of-custody integrity throughout the supply lifecycle. The work is being solicited as a subcontract under the Advanced Research Projects Agency for Health, a division of the Department of Health and Human Services, with a primary focus on accelerating innovative therapeutic development. The solicitation is open for responses until October 15, 2026, and the North American Industry Classification System code 325412 indicates the scope involves pharmaceutical preparations manufacturing. Performance is expected to meet stringent federal standards for investigational drug supply, with no geographical restrictions specified on place of performance, allowing for flexible, secure, and scalable logistical execution across approved facilities.

General Info

Formulate, test, and supply ibogaine compounds for clinical research under federal regulatory standards.

Agency

Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)View 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 → Advanced Research Projects Agency For Health (arpa-H)
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

Show more
Provision of ibogaine or related compounds under IND, including dosing formulation, stability testing, and supply chain logistics.

Similar Contracts

Same NAICS industry code

NAICS: 325412
New
Federal
SUPPLY AND DELIVERY OF MEDICAL SUPPLIES
Solicitation # 19RP3826Q0059
The U.S. Department of State through the U.S. Embassy Manila is soliciting quotations for the supply and delivery of medical supplies under solicitation number 19RP3826Q0059, with a NAICS code of 325412. Offerors must submit their proposals electronically by August 10, 2026, at 4:00 p.m. Philippine local time, using MS-Word 2007/2010, MS-Excel 2007/2010, or Adobe Acrobat PDF formats, with individual files not exceeding 10MB; larger submissions must be split into multiple emails each under the size limit. Proposals must be in English and include the completed SF-1449 form, Section I Pricing, Section 5 Representations and Certifications, and any additional requirements outlined in Section 3 of the solicitation. All offerors must be registered in the System for Award Management (SAM) prior to submission, as mandated by FAR 4.1102, and failure to register will result in non-responsibility determination. Questions regarding the solicitation must be submitted in writing to ManilaContracting@state.gov no later than July 17, 2026, at 4:00 p.m. Philippine local time. The government intends to award a contract to the responsible vendor submitting the lowest priced acceptable offer, potentially holding discussions only if necessary. No details on delivery schedules, inspection criteria, packaging specifications, or evaluation factors are provided in the available documentation.
US Embassy Manila

POSTED

1 day ago

DEADLINE

in 17 days
View Details
NAICS: 325412
New
Federal
Department of War Pharmacy Uniform Formulary Blanket Purchase Agreement/Uniform Formulary Additional Discount Program
Solicitation # HT9402-26-Q-9402
The Department of War, through the Defense Health Agency, is soliciting quotes under RFQ HT9402-26-Q-9402 to support the establishment and maintenance of the Uniform Formulary for the Military Health System, as mandated by 10 U.S.C. § 1074g and 32 CFR § 199.21. The process involves evaluating pharmaceutical agents for clinical and cost effectiveness to determine placement on the Uniform Formulary as generic, formulary, Basic Core Formulary, Extended Core Formulary, or non-formulary, with the goal of optimizing pharmaceutical procurement through Uniform Formulary Blanket Purchase Agreements and Uniform Formulary Additional Discount Program Agreements. Four newly approved drugs—Awiqli Flextouch (basal insulin), Cavhanza (BCR-ABL tyrosine kinase inhibitor for leukemia and lymphoma), Lipfendra (PCSK9 antilipidemic), and Trutakna (nephrology agent)—are scheduled for review at the November 2026 Pharmacy and Therapeutics Committee meeting, and industry responses will inform their inclusion or exclusion. Responses to the RFQ are due by August 27, 2026, with a pre-quotation teleconference scheduled for August 12, 2026, to clarify requirements. Clinical data submissions for evaluation must be sent via email to the designated point of contact by the deadline specified in Part 2.3.2. The solicitation, issued by the Defense Health Agency under NAICS code 325412, is managed from Aurora, Colorado, with performance centered in San Antonio, Texas. Primary contact is Julia Trang, with Stephanie Erpelding as secondary contact, and all submissions and inquiries must adhere to the instructions outlined in RFQ HT9402-26-Q-9402 to be considered valid.
Defense Health Agency

POSTED

1 day ago

DEADLINE

in 20 days
View Details
NAICS: 325412
New
Federal
RABORAL VRG RACCOON BAITS, COATED SACHETS
Solicitation # 1171341
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service is procure up to 6,965,000 units of RABORAL V-RG® oral rabies vaccine baits under a firm fixed price indefinite-delivery/indefinite-quantity contract with a one-year period of performance from September 10, 2026, through September 30, 2027. The acquisition supports wildlife rabies control efforts by providing two licensed bait types—coated sachet (part number 128370) and fishmeal polymer (part number 128425)—both manufactured by Boehringer-Ingelheim Animal Health USA, Inc., containing the same live recombinant vaccine that uses an attenuated Vaccinia virus to deliver the rabies glycoprotein gene, which stimulates immunity without causing rabies. Each bait is labeled with product identification and a toll-free information number. Contracts will be awarded under a single award IDIQ structure, with a stated minimum obligation of $50,000 and a ceiling of $9,000,000, and will require FOB destination delivery to CONUS locations specified at the time of order, with shipping costs included in the unit price. All products must meet strict regulatory standards including valid USDA APHIS Center for Veterinary Biologics licensure, demonstrated efficacy through controlled studies, adherence to current Good Manufacturing Practices, and validated cold chain protocols to maintain potency throughout storage and transit. The evaluation for award is based on technical and regulatory compliance, manufacturing quality and surge capacity, past performance, and price realism, with the government reserving the right to use either the best value trade-off or lowest price technically acceptable method depending on documented justification. Contractors must be registered in SAM with a valid UEI and CAGE code, and must comply with all applicable FAR clauses including those related to whistleblower rights, human trafficking, subcontractor reporting, and ethical conduct, while also meeting strict packaging and labeling requirements for shipment, including proper documentation of SHIP NUMBER, VOUCHER NUMBER, and ITEM NO. Offers must be submitted by September 7, 2026, at 5:00 PM Eastern Time to the designated contracting officer, and all submissions are subject to a strict no-late-submissions policy.
Aphis-Ws

POSTED

1 day ago

DEADLINE

in about 1 month
View Details
NAICS: 325412
New
Federal
Department of War Pharmacy Uniform Formulary Blanket Purchase Agreement/Uniform Formulary Additional Discount Program
Solicitation # HT9402-26-Q-9401
The Department of War, through the Defense Health Agency, is soliciting quotations to support the establishment and maintenance of the Uniform Formulary for the Military Health System, as mandated by federal law and regulation. The process involves evaluating pharmaceutical agents for clinical and cost effectiveness to determine their placement on the formulary tiers—generic, formulary, Basic Core Formulary, Extended Core Formulary, or non-formulary—with the goal of optimizing patient access and managing expenditures. The solicitation includes the potential award of Uniform Formulary Blanket Purchase Agreements and Uniform Formulary Additional Discount Program Agreements contingent upon the Pharmacy and Therapeutics Committee’s recommendations. Two drug classes are under review for the November 2026 meeting: Atopy—Topical Agents including Anzupgo, Eucrisa, Opzelura, Vtama, and Zoryve; and Lung Cancer—METEX14, including Tabrecta and Tepmetko. The request for quotation, identified as HT9402-26-Q-9401, outlines detailed procedures, appendices for BPA and ADP, and key submission deadlines. Responses are required by October 1, 2026, with a mandatory pre-quotation teleconference scheduled for August 12, 2026. The solicitation is issued by the Defense Health Agency under the Department of Defense, with the primary point of contact located in Aurora, Colorado, and performance expected in Texas. Vendors must adhere strictly to the instructions provided in the RFQ to ensure eligibility for consideration under the uniform formulary program, which directly impacts pharmacy benefits for military personnel and their dependents.
Defense Health Agency

POSTED

1 day ago

DEADLINE

in about 2 months
View Details

More opportunities from Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)

Same awarding agency

NAICS: 541611
New
Federal
Operational Execution of Multi-Site Clinical TrialsThe contract titled Operational Execution of Multi-Site Clinical Trials entails the comprehensive management and coordination of clinical trial operations across multiple geographic locations, with core responsibilities including the training and oversight of clinical staff, the implementation of patient recruitment strategies, and the accurate and timely collection of trial data. The scope demands a robust operational framework to ensure protocol adherence, regulatory compliance, and data integrity across all participating sites, requiring experienced personnel with demonstrated expertise in decentralized and multi-site clinical research environments. Issued as a subcontract under the Advanced Research Projects Agency for Health part of the Department of Health and Human Services, this opportunity is governed by NAICS code 541611 and requires proposals to be submitted by October 15, 2026. While the solicitation number and specific address details are not provided, performance is expected to occur across unspecified locations, indicating a nationwide or potentially international operational footprint. The contracting entity seeks entities capable of delivering scalable, efficient, and compliant clinical trial execution without direct oversight, emphasizing autonomy, quality control, and responsiveness in complex, distributed study settings.
Administrative Management and General Management Consulting Services

POSTED

2 days ago

DEADLINE

in 2 months
View Details
NAICS: 621399
New
Federal
Therapeutic Set and Setting Protocol DevelopmentThe contract seeks the development of a comprehensive therapeutic set and setting protocol for the administration of ibogaine, focusing on the design of a safe, supportive, and clinically rigorous environment that optimizes patient outcomes. This includes the creation of structured psychological support systems, detailed patient preparation procedures, and integrated post-treatment protocols to ensure continuity of care and long-term therapeutic benefit. The protocol must be grounded in evidence-based practices and tailored to address the unique physiological and psychological demands of ibogaine therapy, with an emphasis on harm reduction, informed consent, and ethical standards. The work is being procured as a subcontract under the Advanced Research Projects Agency for Health, part of the Department of Health and Human Services, with a submission deadline of October 15, 2026. The project falls under NAICS code 621399, reflecting its focus on specialized medical services involving non-traditional therapeutic modalities. While the place of performance and point of contact details are not specified, the initiative aims to advance clinical frameworks for psychedelic-assisted therapies and requires a multidisciplinary approach integrating medical, psychological, and environmental design elements. Success will depend on delivering a replicable, scalable model that meets federal standards for safety, efficacy, and patient-centered care.
Offices of All Other Miscellaneous Health Practitioners

POSTED

2 days ago

DEADLINE

in 2 months
View Details
NAICS: 541690
New
Federal
Clinical Trial Safety and Risk Mitigation PlanningThe contract pertains to the development of comprehensive safety protocols for ibogaine clinical trials, with a focus on mitigating risks associated with its use in therapeutic settings. Key components include the implementation of rigorous cardiotoxicity monitoring systems to detect and manage potential cardiac adverse events, detailed assessments of drug interactions to prevent harmful combinations, and the establishment of dose de-escalation strategies to ensure patient safety across varying treatment phases. These protocols are intended to support the responsible and scientifically sound advancement of ibogaine research, particularly in contexts where safety concerns have historically hindered clinical progress. This subcontract is issued under the auspices of the Advanced Research Projects Agency for Health, a division of the Department of Health and Human Services, reflecting a federal commitment to advancing innovative but high-risk therapeutic modalities. The work is to be completed in response to a solicitation posted on August 5, 2026, with proposals due by October 15, 2026. The NAICS code 541690 indicates the nature of the work involves other scientific and technical consulting services, aligning with the specialized expertise required for designing and validating complex clinical safety frameworks. The place of performance and point of contact details are unspecified, suggesting flexibility in execution location while maintaining strict adherence to federal safety and compliance standards.
Other Scientific and Technical Consulting Services

POSTED

2 days ago

DEADLINE

in 2 months
View Details
NAICS: 541711
New
Federal
Integrated Phase I/II Clinical Trial DesignThe contract seeks the design and protocol development for an integrated Phase I/II clinical trial to evaluate ibogaine as a potential treatment for opioid use disorder, focusing on safety, optimal dosing, and therapeutic efficacy. The effort requires a comprehensive clinical framework that seamlessly merges the objectives of Phase I, which prioritizes dose escalation and toxicity profiling, with those of Phase II, which assesses preliminary effectiveness in reducing opioid dependence and withdrawal symptoms. The protocol must adhere to rigorous scientific and regulatory standards, incorporating appropriate patient selection criteria, monitoring procedures, endpoints, and risk mitigation strategies for a substance with significant pharmacological and safety considerations. The work is being pursued as a subcontract under the Advanced Research Projects Agency for Health, part of the Department of Health and Human Services, with a NAICS code indicating research and development in the life sciences. The solicitation was posted on August 5, 2026, and responses are due by October 15, 2026. The project is situated within a broader initiative to advance novel therapeutic interventions for the opioid crisis, requiring innovative trial design that balances exploratory research with clinical feasibility. There is no specified set-aside designation or location restriction for performance, indicating flexibility in execution while emphasizing scientific merit and regulatory alignment as key evaluation criteria.
Research and Development in Biotechnology

POSTED

2 days ago

DEADLINE

in 2 months
View Details
NAICS: 541611
Federal
Regulatory Strategy and FDA Alignment ConsultingThe contract seeks specialized consulting services to develop and implement a regulatory strategy aligned with FDA quality assurance standards, ensuring that system outputs are positioned for successful approval or adoption under applicable regulatory pathways. The work focuses on providing expert guidance to navigate the complexities of federal regulatory requirements, with particular emphasis on health technology systems undergoing evaluation by the Food and Drug Administration. The contractor must demonstrate a deep understanding of FDA processes, including validation, documentation, and compliance frameworks, to support the development of defensible, scalable, and FDA-ready solutions. This subcontract is issued by the Advanced Research Projects Agency for Health under the Department of Health and Human Services, with a place of performance in Washington DC, 20005. The opportunity is classified under NAICS code 541611 for management consulting services and is open for responses until August 20, 2026. While no specific set-aside designation is provided, the solicitation is structured to attract qualified entities capable of delivering strategic regulatory advisory services to federal health innovation initiatives. The contract aims to accelerate the translation of advanced health technologies into clinically adopted solutions by embedding regulatory compliance early and systematically into the development lifecycle.
Administrative Management and General Management Consulting Services

POSTED

10 days ago

DEADLINE

in 13 days
View Details
NAICS: 541714
Federal
Multimodal Sensor Integration and Signal Fusion EngineeringThe contract seeks integration of multiple sensing modalities into a unified platform designed for real-time pharmaceutical inspection, emphasizing synchronized signal correlation and advanced noise reduction techniques. The project requires the engineering of a robust system capable of fusing data from diverse sensor types to enhance detection accuracy, reliability, and speed in identifying product defects or anomalies during manufacturing processes. Development must ensure temporal and spatial alignment of signals, adaptive filtering for environmental and operational interference, and seamless interoperability across hardware and software components to support continuous, high-fidelity monitoring. This subcontract, under NAICS code 541714 and sponsored by the Advanced Research Projects Agency for Health within the Department of Health and Human Services, targets innovation in sensor fusion technologies with a specific focus on quality assurance in pharmaceutical production. The place of performance is designated as Washington DC with a zip code of 20005, and proposals must be submitted by August 20, 2026. The initiative aims to advance detection capabilities beyond conventional single-sensor approaches, enabling next-generation inspection systems that meet stringent regulatory standards through data-driven, real-time analytics.
Research and Development in Biotechnology (except Nanobiotechnology)

POSTED

10 days ago

DEADLINE

in 13 days
View Details
NAICS: 541715
Federal
AI/ML Models for Drug Composition VerificationThe contract seeks the development of advanced machine learning algorithms to non-invasively verify drug identity, detect contaminants, and identify substandard pharmaceutical formulations by analyzing multi-sensor data without requiring penetration of the container. This effort is focused on creating robust AI models capable of interpreting complex sensor inputs to ensure drug quality and safety, supporting regulatory and public health objectives through innovative, contactless analysis. The work must be completed within a strict timeline, with proposals due by August 20, 2026, and is classified as a subcontract under NAICS code 541715, indicating a focus on research and development in the physical, engineering, and life sciences. The contracting agency is the Advanced Research Projects Agency for Health, part of the U.S. Department of Health and Human Services, and the performance location is designated as Washington, D.C. with a ZIP code of 20005. While no set-aside provisions or specific point of contact are provided, the solicitation emphasizes technological innovation in pharmaceutical verification, targeting solutions that enhance supply chain integrity and public health outcomes. The absence of a solicitation number and detailed office address suggests this may be an internal or pre-solicitation notice, but the clear deadline and agency affiliation indicate active planning for future contracting actions.
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

10 days ago

DEADLINE

in 13 days
View Details