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

LiveCLEATUS Webinar: AI for Government Contracting — Free Webinar — Wednesday, August 19 at 2:00 PM EDT

Register Free →

Search

Top

Back to Contracts

Medical Writing for Regulatory Submissions

Active

Federal

Response Deadline08/19/2026, 02:30:00 PM UTC

Contract Overview

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

General Info

Agency

Department Of Health And Human Services → National Institutes Of Health NichdView Agency

NAICS

541930 - Translation and Interpretation ServicesView NAICS

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

SBA

Documents

This scope was carved out of 75N98026R00147.

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

View the prime solicitation

Rare Disease Regulatory Operations Support Consultant

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

PostedAug 12

subcontract

Response DeadlineAug 19

Submission deadline

Response Deadline

08/19/2026, 02:30:00 PM UTCin 6 days

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 → National Institutes Of Health Nichd

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health Nichd

View Agency Profile

Office AddressN/A

ContactsNo contact information available

Full Description

Show more

Prepare regulatory documents including clinical study reports, protocols, investigator brochures, and dossiers (IMPD, MAA) in compliance with FDA/EMA standards such as eCTD.

Similar Contracts

Same NAICS industry code

Documentation and Reporting Services

Office Of The Chief Procurement Officer

POSTED

DEADLINE

Writer/Editor for Event Content & Reporting

POSTED

DEADLINE

ASL Interpreting and CART Services

Solicitation # ASU-RFP 162701

Arizona State University is seeking multiple qualified providers to deliver ASL interpreting and Communication Access Realtime Translation services through the ASU SAILS program. The goal of this solicitation is to establish a flexible, on-demand network of speech-to-text and interpreting professionals to ensure accessible university experiences for students with diverse needs. Interested parties must submit their responses by August 25, 2026, in accordance with solicitation number ASU-RFP 162701. The primary point of contact for this opportunity is Jaydi Ramirez, and further details can be accessed via the university's procurement portal.

Arizona State University

POSTED

DEADLINE

Multilingual Language Interpretation ServicesThe Housing Authority of Cook County is seeking a subcontractor to provide multilingual language interpretation services for non-English-speaking residents. The selected provider will deliver both on-demand and scheduled interpretation via telephone or through the use of bilingual agents to ensure effective communication within HACC housing. This opportunity is categorized under NAICS code 541930 and is based in Chicago. Interested parties must submit their responses by the deadline of September 9, 2026, following the posting date of August 11, 2026.

Housing Authority of Cook County

POSTED

DEADLINE

Content Strategy & Narrative Development

Department Of Environmental Services

POSTED

DEADLINE

in about 1 month

Real-Time Translation and Multilingual Support Services

Nswc Indian Head Division

POSTED

DEADLINE

Interpretation and Translation Services

US Embassy Bogota

POSTED

DEADLINE

Audit Report Production and Technical Documentation

Southeastern Power Administration

POSTED

DEADLINE

Technical Documentation & Knowledge Base Authoring

Omas Strategic Buying Center - Information Technology

POSTED

DEADLINE

Simultaneous Interpretation and Translation Services

US Embassy Tbilisi

POSTED

DEADLINE

Department of War Language Interpretation and Translation Enterprise (DLITE) III DRAFT Solicitation

Solicitation # DLITEIII

The Department of War Language Interpretation and Translation Enterprise (DLITE) III is an Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract under NAICS 541930, managed by the Department of Defense. The program has a total ceiling of 3.5 billion dollars and spans a ten-year period, consisting of a five-year base ordering period and a five-year option period. The scope of work involves providing comprehensive linguist support services, including translation and interpretation, across two primary mission areas: Force Projection and Train and Sustain. These services are performed worldwide in various environments, ranging from military installations to austere field locations, with labor pricing and specific deliverables determined at the individual task order level. Award eligibility is based on a two-phase evaluation process consisting of a compliance review and a points-based Q-Card scoring system. To qualify for an IDIQ award, offerors must be determined responsible, submit compliant proposals, offer reasonable pricing, and achieve a minimum threshold of 4,976 points on their Q-Card. The contract maintains rigorous security requirements, necessitating a Top Secret with Sensitive Compartmented Information (TS/SCI) clearance for personnel and a Top Secret Facility Clearance (FCL) for the organization. Quality is monitored through a Government-led Quality Assurance Surveillance Plan (QASP) and a contractor-developed Quality Control Plan (QCP), with invoicing processed electronically via Wide Area WorkFlow (WAWF).

POSTED

DEADLINE

Translation and Interpretation Services (BAMC)

Solicitation # W81K0026RA042

This solicitation, identified as W81K0026RA042, seeks a small business contractor to provide comprehensive medical and legal interpretation and translation services at Brooke Army Medical Center and its affiliated clinics in Fort Sam Houston, Texas. The contractor must supply CCHI and/or NBCMI-certified personnel to deliver verbal and written services in a wide array of languages, including but not limited to American Sign Language, Arabic, Mandarin, Spanish, Russian, and Vietnamese, with immediate on-site, video remote, and telephonic interpretation available within five minutes of request. The contract is structured as an indefinite-delivery, indefinite-quantity (IDIQ) with a base period from October 1, 2026, through September 30, 2031, and includes up to four option years plus a potential six-month extension. All services must comply with HIPAA, DoD, and Army regulations, and the contractor is required to implement a Quality Assurance Surveillance Plan and maintain performance documentation for five years post-contract. The solicitation mandates strict cybersecurity compliance, requiring that all Video Remote Interpretation (VRI) solutions operate via standard web protocols (TCP 80/443) with no client software installed on government systems; vendors must possess an active Department of Defense Authority to Operate (ATO) to demonstrate prior cyber-testing of their platforms. Proposals must be submitted in four volumes—Technical Approach, Risk Management Framework Compliance, Past Performance, and Price—using specified attachments and templates, with pricing provided via an Excel worksheet. The award will follow a Lowest Price Technically Acceptable (LPTA) method, where all non-cost factors must be rated acceptable to be eligible; failure to complete the Medical Device Risk Assessment form or provide valid past performance references will render a proposal ineligible. The acquisition is set aside exclusively for small businesses as defined under NAICS code 541930, and offerors must comply with a range of federal and defense regulations, including safeguarding covered defense information, avoiding prohibited equipment sources, and ensuring contractor personnel meet immunization and identification badge requirements. Proposals are due by August 3, 2026, and must be submitted electronically to designated government email addresses.

POSTED

DEADLINE

in about 3 hours

More opportunities from Department Of Health And Human Services → National Institutes Of Health Nichd

Same awarding agency

Nonclinical and Clinical Development Oversight via CROs/CMOs

Administrative Management and General Management Consulting Services

POSTED

DEADLINE

Regulatory Strategy and FDA/EMA Submission Support

Administrative Management and General Management Consulting Services

POSTED

DEADLINE

EU Orphan Drug Designation Sponsorship and Regulatory Representation

Administrative Management and General Management Consulting Services

POSTED

DEADLINE

Biological Therapeutics Product Development Subject Matter Expert Consulting Services

Solicitation # 75N98026R00148

The National Institutes of Health Office of the Director is conducting a market survey to identify qualified small businesses capable of providing subject matter expert consultants for gene-based therapeutics development. These consultants will offer technical recommendations and advice to support the translational development of novel biologics for NIH drug discovery and development programs. This procurement is classified under NAICS code 541690 and is intended as a total small business set-aside, including specific interest in 8(a), woman-owned, service-disabled veteran-owned, and HUBZone small businesses. Interested firms must submit a detailed capability statement demonstrating their experience and skills to Tina Robinson via email by 10:30 am EDT on August 19, 2026. Submissions must reference solicitation number 75N98026R00148 and include a point of contact with the authority to discuss the response. The capability statement should be accompanied by descriptive literature, delivery timeframes, and warranties to ensure a comprehensive evaluation of the firm's ability to meet the government's requirements.

Other Scientific and Technical Consulting Services

POSTED

DEADLINE

Rare Disease Regulatory Operations Support Consultant

Solicitation # 75N98026R00147

The National Institutes of Health Office of the Director is conducting a market survey to identify qualified small businesses capable of providing international regulatory consultancy services. The scope of work focuses on International Orphan Drug Designation Sponsor/Representation and European Medicines Agency consultancy. This procurement is classified under NAICS code 541690 with a size standard of 19 million dollars and is intended as a small business set-aside, including various categories such as 8(a), woman-owned, and service-disabled veteran-owned businesses. Interested firms must submit a detailed capability statement demonstrating their experience and skills to Tina Robinson via email by 10:30 am EDT on August 19, 2026. Submissions must reference solicitation number 75N98026R00147 and include a point of contact, descriptive literature, delivery timeframes, and warranties. This notice is for information and planning purposes to determine the availability of qualified vendors and does not constitute a formal commitment by the government.

Other Scientific and Technical Consulting Services

POSTED

DEADLINE

Chemistry Research for the Division of Translational Toxicology (DTT)

Solicitation # 75N94026R00002

The National Institute of Environmental Health Sciences (NIEHS), through its Division of Translational Toxicology (DTT), is seeking chemistry research support to advance the National Toxicology Program’s mission of understanding how environmental factors impact human health. This acquisition, identified by solicitation number 75N94026R00002, is a market research effort aimed at identifying qualified vendors capable of providing comprehensive chemistry services across eight functional areas: Logistics and Handling, Characterization, Formulation, Biosample Analysis, Special Studies, Animal Studies, Omics, and In Vitro Assays. The contractor will be responsible for end-to-end chemistry support, including handling hazardous materials, developing and validating analytical methods, conducting toxicokinetic and ADME studies, and ensuring compliance with FDA Good Laboratory Practices, DOT regulations for chemical transport, and NCI guidelines. Work is to be performed at the contractor’s facilities, coordinated closely with DTT in Bethesda, Maryland, where all data and reports must be submitted electronically through the DTT Program Management System in accordance with Section 508 accessibility standards. The anticipated contract structure includes a ten-year base period with an optional six-month extension, and the government expects to use a Cost Plus Fixed-Fee contract type. Evaluation of future proposals will prioritize technical performance, with Logistics and Handling carrying the highest weight at 30%, followed by key areas such as Biosample Method Development and Chemical Identity and Purity at a weight of five. Proposals must include detailed Quality Management Plans, Health and Safety Plans, and IT Security Plans, all of which must be approved prior to work commencement. Key personnel, including the Principal Investigator and Quality Assurance Officer, must be direct employees of the prime contractor, and subcontractors may not fulfill these roles. Facilities involved in animal work must hold AAALAC accreditation and maintain an active IACUC, while the prime contractor must hold DEA licensing for controlled substances. The solicitation requires respondents to submit a single 15-page Capability Statement via email by March 4, 2026, with the document limited to Word or PDF formats. While this posting is for market research and not a formal solicitation, it sets the stage for a future contract with no set-aside classification under NAICS code 541715, and the government will consider all business sizes in the selection process. Financial and administrative details, including payment methods and accounting codes, will be finalized in the subsequent Request for Proposal.

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

DEADLINE

Surge Capacity and Temporary IT SupportThe contract titled "Surge Capacity and Temporary IT Support" is a subcontract issued by the National Institutes of Health NICHD, part of the Department of Health and Human Services. Its primary purpose is to provide on-demand IT staffing solutions designed to manage peak workloads, handle emergencies, and fill short-term gaps in IT operations. This flexible support ensures that critical IT functions remain uninterrupted during periods of increased demand or unexpected staff shortages. The contract falls under the NAICS code 561320, which pertains to temporary help services. Work associated with this contract will be performed in Bethesda. Although specific details such as solicitation number, point of contact, and exact office address are not provided, the contract is aimed at augmenting the agency’s IT capabilities through timely and scalable staffing resources. This approach enables the NIH NICHD to maintain operational efficiency and responsiveness in its IT environment.

Temporary Help Services

POSTED

DEADLINE

Telecommunications and Network SupportThis contract involves providing comprehensive telecommunications infrastructure support along with coordination of voice and data networks, ensuring seamless integration with the National Institutes of Health (NIH) wide communications systems. The work is focused on maintaining and enhancing telecom capabilities, supporting the operational needs of NIH’s communication framework. The subcontract is designated under NAICS code 517110, which pertains to wired and wireless telecommunications carriers. The contract is issued by the National Institutes of Health, specifically the NICHD office within the Department of Health and Human Services. The primary place of performance is Bethesda, supporting NIH's ongoing efforts to maintain robust and reliable network infrastructure. The scope includes technical support for voice and data systems, network coordination, and integration tasks that align with NIH's overarching communication system goals. Though solicitation details and set-aside information are not provided, the contract facilitates critical backend infrastructure enhancement to support NIH’s research and administrative operations.

Wired Telecommunications Carriers

POSTED

DEADLINE

Data Center Operations and Hosting CoordinationThis contract involves providing comprehensive support for data center infrastructure operations, including server monitoring, hosting services, storage coordination, and timely response to outages. It is a subcontract under the NAICS code 518210, which pertains to data processing, hosting, and related services. The contract is issued by the National Institutes of Health NICHD, part of the Department of Health and Human Services, with the place of performance located in Bethesda. The primary focus is to ensure the reliable and efficient operation of the data center's technical environment by maintaining continuous server oversight and facilitating hosting and storage management. Additionally, the contractor is responsible for addressing any service disruptions promptly to minimize downtime. This arrangement is crucial for maintaining the operational integrity and availability of the agency’s IT infrastructure supporting its research and administrative activities.

Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services

POSTED

DEADLINE

Executive and Administrative SupportThis contract is established to provide high-level administrative support services to the Office of the Chief Information Officer (OCIO) leadership at the National Institutes of Health, specifically within the NICHD division under the Department of Health and Human Services. The scope of work includes key administrative functions such as scheduling, managing correspondence, coordinating meetings, and handling executive communications to ensure smooth and efficient operations for the leadership team. The contract is designated as a subcontract under the NAICS code 561410, which covers office administrative services. The work will be performed primarily in Bethesda, although specific state and zip code details are not provided. This contract aims to facilitate the administrative needs of OCIO leadership by streamlining their communication and organizational tasks, ultimately supporting effective management and decision-making. The status and additional details of the contract can be accessed through the provided SAM.gov link, with the process initiated on June 11, 2026.

Document Preparation Services

POSTED

DEADLINE

Property and Network Security AdministrationThis contract involves the management of both physical and logical access controls, ensuring secure and authorized entry to facilities and network resources. It includes comprehensive asset tracking to monitor and safeguard organizational property effectively. Additionally, the contract emphasizes maintaining cybersecurity compliance, aligning with established standards to protect sensitive information and systems. Coordination with Identity, Credential, and Access Management (ICAM) is also a key component, ensuring integrated and streamlined security protocols. The contract is titled "Property and Network Security Administration" and is a subcontract issued by the National Institutes of Health NICHD under the Department of Health and Human Services. The work will be performed in Bethesda, aligning with NAICS code 541990, which typically covers specialized professional services. Though solicitation details and specific points of contact are not provided, the contract underscores a focus on securing both physical properties and network infrastructure to support the agency’s mission-critical operations.

All Other Professional, Scientific, and Technical Services

POSTED

DEADLINE

Application Development and ModernizationThis contract involves providing support for the development, maintenance, and modernization of enterprise applications used by the National Institutes of Health (NIH) Center for Information Technology (CIT) and the Office of the Chief Information Officer (OCIO). Key activities include cloud migration, application integration, and modernization efforts aimed at improving the technological infrastructure supporting NIH operations. The work is focused on ensuring these critical applications remain efficient, secure, and up-to-date with current technology standards. The contract is a subcontract under the NAICS code 541512, related to computer systems design services. The place of performance is Bethesda, Maryland, where NIH headquarters are located. The contract is managed under the Department of Health and Human Services through the NIH's National Institute of Child Health and Human Development (NICHD). This initiative supports NIH’s ongoing commitment to leveraging advanced IT solutions to enhance research and administrative capabilities.

Computer Systems Design Services

POSTED

DEADLINE