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, September 2 at 2:00 PM EDT

Register Free →
logo
Get CLEATUS

Manufacturing Scale-Up and Process Development

Active
SBIR / STTR

Contract Overview

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

AI Contract Overview

Show more

This subcontract opportunity with the Department of Health and Human Services focuses on the manufacturing scale-up and process development of therapeutics. The primary objective is to transition production from a laboratory setting to GMP-compliant manufacturing, which involves comprehensive process optimization and the implementation of rigorous quality systems. The project is designated as a total small business set-aside under the SBIR/STTR mandate for companies with fewer than 500 employees, falling under NAICS code 325412. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027.

General Info

HHS small business subcontract for GMP therapeutic manufacturing scale-up and process development.

Agency

Department of Health and Human ServicesView Agency

NAICS

325412 - Pharmaceutical Preparation ManufacturingView NAICS

Place of Performance

Not specified

Set-Aside

SBA

Documents

This scope was carved out of PAR-27-098.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)

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
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department of Health and Human Services
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

Show more
Scale up production from lab to GMP-compliant manufacturing for therapeutics, including process optimization and quality system implementation.

Similar Contracts

Same NAICS industry code

NAICS: 325412
New
DIBBS
DEXTROSE INJECTION
Solicitation # SPE2DP-26-T-4667
Solicitation SPE2DP-26-T-4667 is a Request for Quotations issued by the DLA Troop Support Medical Supply Chain Pharm FSA for the procurement of Dextrose 5% Injection, USP, 100 ML, in packages of 80 units. The requirement is identified by NSN 6505-01-384-1362 and specifies a quantity of one package. The product must adhere to United States Pharmacopeia standards and has a non-extendable shelf life of 24 months. Delivery is required within 20 days after receipt of order, with the point of delivery, inspection, and acceptance all set as destination at Fort Bragg, North Carolina. The contract mandates strict adherence to Medical Marking Standard No. 1, which supersedes MIL-STD-129, and requires packaging in accordance with MIL-STD-2073-1E and special instructions MPWM00001. All shipping must utilize suitable commercial exterior containers to ensure safe delivery. Administratively, the contractor must use the Wide Area WorkFlow system for electronic invoicing and payment requests. The solicitation incorporates various FAR and DFARS clauses, including the Buy American Act, safeguarding of covered defense information, and hazardous material labeling standards under 29 CFR 1910.1200. Quotations must be submitted via the DLA Internet Bid Board System.
MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

about 8 hours ago

DEADLINE

in 1 day
View Details
NAICS: 325412
New
DIBBS
BENZONATATE CAPSULES
Solicitation # SPE2DP-26-T-4764
This contract is for the procurement of Benzonatate Capsules, USP, 100 mg, provided in bottles of 100 units. The medication is regulated by the FDA and must be stored at a controlled room temperature between 20 and 25 degrees Celsius, protected from light, moisture, and humidity. The item carries a non-extendable shelf life of 36 months and must adhere to specific DLA packaging and medical marking standards. The order consists of one bottle under solicitation SPE2DP-26-T-4764, with delivery required within five days after the order. The contract specifies delivery, inspection, and acceptance at the destination point with a zero percent quantity variance. It incorporates various technical and quality requirements from the DLA master list and requires the removal of government identification from any non-accepted supplies.
MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

about 8 hours ago

DEADLINE

in 6 days
View Details
NAICS: 325412
New
DIBBS
POVIDONE-IODINE CLEANS
Solicitation # SPE2DP-26-T-4657
Solicitation SPE2DP-26-T-4657 is a fixed-price request for quotations issued by DLA Troop Support Medical Supply Chain for the procurement of Povidone-Iodine Cleansing Solution, USP, with a 7.5% active ingredient. The product is for external use only and is supplied in one-gallon bottles. Key technical requirements include a total shelf life of 36 months, with at least 31 months remaining upon delivery to the first government activity. Storage must be maintained at 25 degrees Fahrenheit, with permitted excursions between 15 and 30 degrees Celsius. The procurement consists of multiple line items with total quantities across various delivery locations, including Whiteman AFB, USS Stethem DDG 63, and USS Winston S Churchill DDG 81. Delivery is required within five days of award, with original required delivery dates set for August 18 and 19, 2026. Shipping is FOB Destination, and inspection and acceptance will occur at the destination. Packaging must comply with DLA Master List requirements, with non-hazardous materials following ASTM D3951 and hazardous materials adhering to TQ requirement IP025. Marking must follow Medical Marking Standard No. 1, which supersedes MIL-STD-129. Suppliers are required to submit Safety Data Sheets (SDS) and labels in accordance with OSHA Hazard Communication Standards and Federal Standard No. 313-E. The contract also mandates compliance with the Buy American Act, the Berry Amendment, and DFARS safeguarding requirements for covered defense information.
MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

about 8 hours ago

DEADLINE

in 1 day
View Details
NAICS: 325412
New
DIBBS
FLUORESCEIN SODIUM OPH
Solicitation # SPE2DP-26-T-4768
This contract is for the procurement of Fluorescein Sodium Ophthalmic Strips, specifically 1 mg strips provided in individually sealed packages of 100 units. The items must be delivered FOB Destination within five days of order and adhere to strict medical packaging and marking standards, specifically Medical Marking Standard No. 1. Labels must include the NSN, manufacturer, CAGE code, date of manufacture, expiration or retest date, and the contract or lot number. The product is FDA regulated and carries a non-extendable shelf life of 36 months. Suppliers must comply with Hazard Communication Standard Notice requirements, including the submission of Safety Data Sheets and compliant labeling prior to award. Additionally, the contract prohibits the intentional addition of mercury or mercury-containing compounds to the supplies. Technical and quality requirements are governed by the DLA Master List, and the procurement is managed by the Department of Defense Medical Supply Chain.
MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

about 8 hours ago

DEADLINE

in 6 days
View Details
NAICS: 325412
New
DIBBS
POVIDONE-IODINE CLEANS
Solicitation # SPE2DP-26-T-4767
This contract is for the procurement of Povidone-Iodine Cleansing Solution, USP 7.5%, delivered in one gallon bottles. The product is regulated by the FDA and must be stored at 25 degrees Celsius, with permitted excursions between 15 and 30 degrees Celsius. A total shelf life of 36 months is required, with at least 31 months remaining upon delivery to the first government activity. The order consists of two line items, each for 4 bottles, with a required delivery date of August 28, 2026, and a delivery window of 5 days. Shipments are destined for the USS Makin Island (LHD 8) and must adhere to strict DLA packaging and marking standards, including Medical Marking Standard No. 1. Additionally, suppliers must comply with the Hazard Communication Standard by providing updated Safety Data Sheets and compliant labeling prior to the award.
MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

about 8 hours ago

DEADLINE

in 6 days
View Details
NAICS: 325412
New
DIBBS
ATIPAMEZOLE HYDROCH
Solicitation # SPE2DP-26-T-4765
This contract is for the procurement of Atipamezole Hydrochloride Injection, a veterinary medication used exclusively in dogs to reverse the effects of medetomidine HCl. The product is specified as a 5 mg/ml active ingredient provided in a 10 ml multi-dose vial, intended for intramuscular administration. It must be stored at controlled room temperature and adheres to a non-extendable shelf life of 36 months. The order consists of one vial under solicitation SPE2DP-26-T-4765 for the Department of Defense, specifically the Medical Supply Chain Pharm FSA. Delivery is required within five days of order to the destination at Eglin AFB. The procurement is subject to FDA regulation and must comply with DLA packaging and medical marking standards, including specific technical and quality requirements for government identification and covered defense information.
MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

about 8 hours ago

DEADLINE

in 6 days
View Details
NAICS: 325412
New
DIBBS
NYSTATIN OINTMENT
Solicitation # SPE2DP-26-T-4687
This contract is for the procurement of Nystatin Ointment, USP, provided in 15 gram tubes. The requirement specifies a total quantity of 84 units with a strict zero percent quantity variance. The product must be stored at a controlled room temperature between 15 and 30 degrees Celsius and must not be frozen. It is subject to a non-extendable shelf life of 36 months. The procurement is managed by the Department of Defense Medical Supply Chain Pharmacy FSA and requires compliance with DLA packaging requirements and Medical Marking Standard No. 1. Delivery is set for five days after order, with FOB destination for both inspection and acceptance. Approved manufacturers include Clay-Park Laboratories, National Pharmaceutical Mfg Co, and Padagis US LLC. All supplies must be FDA regulated and adhere to specific technical and quality requirements outlined in the DLA master list.
MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

about 8 hours ago

DEADLINE

in 1 day
View Details
NAICS: 325412
New
DIBBS
Supply of Individual Medical Components for IFAK Kit
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

1 day ago

DEADLINE

in 5 days
View Details
NAICS: 325412
New
DIBBS
Manufacturing of Benzalkonium Chloride Impregnated Towelettes
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

1 day ago

DEADLINE

in 5 days
View Details
NAICS: 325412
New
DIBBS
Supply of Orthopedic Surgical Cement SetsThis subcontract involves the manufacture and supply of FDA-regulated orthopedic surgical cement sets for the Department of Defense, specifically through the Medical Supply Chain MD Surg FSF. Each set must contain 40 grams of sterile powder mix and strictly adhere to all regulations regarding shelf-life, labeling, and the handling of hazardous materials. The contract is categorized under NAICS code 325412 and is to be performed in Williamsburg, Virginia. Interested parties must submit their responses by August 31, 2026, following the posting date of August 25, 2026.
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

1 day ago

DEADLINE

in 5 days
View Details
NAICS: 325412
New
DIBBS
Pharmaceutical Manufacturing of Moxifloxacin Hydrochloride TabletsThe Defense Logistics Agency within the Department of Defense is seeking a subcontractor for the pharmaceutical manufacturing of Moxifloxacin Hydrochloride Tablets. The scope of work involves cGMP-compliant manufacturing, formulation, and quality control testing to ensure all products meet both military and FDA standards. This opportunity falls under NAICS code 325412 and was posted on August 25, 2026. Interested parties must submit their responses by the deadline of August 31, 2026.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

in 5 days
View Details
NAICS: 325412
New
DIBBS
Supply of Arsenic Test Kits (Commercial Off-the-Shelf)
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

1 day ago

DEADLINE

in 5 days
View Details

More opportunities from Department of Health and Human Services

Same awarding agency

NAICS: 541611
Federal
OHS Region 11 Training and Technical Assistance Network
Solicitation # 7571MN26C00013
The Department of the Interior’s existing contract with ICF Incorporated, LLC, numbered 140D0425C0027, has been administratively transferred to the Department of Health and Human Services under a new task order, 7571MN26C00013, effective July 1, 2026. This transfer is purely administrative and does not alter the original contract’s scope of work, deliverables, ultimate value, or period of performance. The work continues under the same terms and conditions, now managed by HHS to support the OHS Region 11 Training and Technical Assistance Network, with performance based in Reston, Virginia, and administrative oversight from Washington, DC. The contract, classified under NAICS code 541611, remains unrestricted with no set-aside requirements and is fully maintained under the original contractor’s responsibility. Point of contact for inquiries includes Carla Carter and Hamed Hassanzadeh Makou at HHS.
Administrative Management and General Management Consulting Services

POSTED

about 2 months ago

DEADLINE

N/A
View Details
NAICS: 541511
Federal
Portfolio Management System (OPS)
Solicitation # 7571MN26F80053
The Department of the Interior’s contract GS35F523BA/140D0422F0466, originally awarded to the Community Development Institute on May 11, 2022, for the Portfolio Management System (OPS), has been administratively transferred to the Department of Health and Human Services under the new contract number GS35F523BA/7571MN26F80053, effective June 12, 2026. This transfer does not modify any existing terms, including the ultimate contract value or the period of performance, and all scope of work, deliverables, and contractual obligations remain unchanged. The contract, identified by NAICS code 541511, is managed by HHS with the primary point of contact being Amber Harris at amber.harris@hhs.gov, and the work is performed in Madison, Wisconsin, while the contracting office is located in Washington, D.C. The contract notice was posted on June 15, 2026, and the change is purely administrative, with no impact on the contractor or the execution of the project.
Custom Computer Programming Services

POSTED

2 months ago

DEADLINE

N/A
View Details
NAICS: 541611
SBIR / STTR
Commercialization and Market Analysis Consulting
Administrative Management and General Management Consulting Services

POSTED

3 months ago

DEADLINE

in 7 months
View Details
NAICS: 518210
SBIR / STTR
Data Management and EDC System Hosting
Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services

POSTED

3 months ago

DEADLINE

in 7 months
View Details
NAICS: 325412
SBIR / STTR
Manufacturing of Clinical-Grade Materials (CMC)
Pharmaceutical Preparation Manufacturing

POSTED

3 months ago

DEADLINE

in 7 months
View Details
NAICS: 541611
SBIR / STTR
Clinical Trial Design and Biostatistical Analysis
Administrative Management and General Management Consulting Services

POSTED

3 months ago

DEADLINE

in 7 months
View Details
NAICS: 541611
SBIR / STTR
Regulatory Strategy and Submission Support
Administrative Management and General Management Consulting Services

POSTED

3 months ago

DEADLINE

in 7 months
View Details
NAICS: 541611
SBIR / STTR
Preclinical Laboratory Testing Services
Administrative Management and General Management Consulting Services

POSTED

3 months ago

DEADLINE

in 7 months
View Details
NAICS: 541512
SBIR / STTR
Cybersecurity and Data Protection ComplianceThe Department of Health and Human Services is seeking a subcontractor for a project focused on Cybersecurity and Data Protection Compliance. The primary objective is to ensure the protection of sensitive research data by adhering to NIST SP 800-171, HIPAA, and other federal cybersecurity requirements. This opportunity is categorized under NAICS code 541512 and is designated as a Total Small Business Set-Aside, specifically targeting firms with fewer than 500 employees under the SBIR/STTR mandate. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027. Interested parties can find further details through the provided SBIR portal link.
Computer Systems Design Services

POSTED

3 months ago

DEADLINE

in 7 months
View Details
NAICS: 541620
SBIR / STTR
Data Management and Biostatistical AnalysisThis subcontract with the Department of Health and Human Services focuses on the management and biostatistical analysis of preclinical and clinical datasets. The primary objective is to utilize biostatistical methods and regulatory-compliant data standards to ensure the integrity and analysis of research data. The opportunity is designated as a Total Small Business Set-Aside under the SBIR/STTR mandate for companies with fewer than 500 employees, falling under NAICS code 541620. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027.
Environmental Consulting Services

POSTED

3 months ago

DEADLINE

in 7 months
View Details
NAICS: 541690
SBIR / STTR
Regulatory Strategy and Submission SupportThe Department of Health and Human Services is seeking a subcontractor to provide specialized regulatory consulting and support for FDA submissions. The scope of work includes the preparation of Investigational New Drug, Investigational Device Exemption, Biologics License Application, or 510(k) filings, as well as managing interactions with the agency. This opportunity is designated as a Total Small Business Set-Aside under the SBIR/STTR mandate for companies with fewer than 500 employees, falling under NAICS code 541690. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027.
Other Scientific and Technical Consulting Services

POSTED

3 months ago

DEADLINE

in 7 months
View Details
NAICS: 621999
SBIR / STTR
Clinical Trial Execution (Phase I/II)The Department of Health and Human Services is seeking a subcontractor for Clinical Trial Execution focusing on Phase I and II trials. The scope of work involves the comprehensive design and management of early-phase clinical trials, specifically covering site selection, patient recruitment, monitoring, and data collection. This opportunity is designated as a Total Small Business Set-Aside under the SBIR/STTR mandate for companies with fewer than 500 employees. The solicitation was posted on May 28, 2026, and the deadline for responses is April 6, 2027. The contract falls under NAICS code 621999.
All Other Miscellaneous Ambulatory Health Care Services

POSTED

3 months ago

DEADLINE

in 7 months
View Details