This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on November 30, 2024. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products

Closed

75N95025R00005Federal

Submission Closed02/03/2025, 08:00:00 PM UTC

Contract Overview

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

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NAICS: 325412

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MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

1 day ago

DEADLINE

in 6 days

AI Contract Overview

This contract involves providing comprehensive Chemistry, Manufacturing, and Controls (CMC) services to support the development of human therapeutics within the framework of the National Center for Advancing Translational Sciences. The contractor will be responsible for ensuring the production of high-quality formulated drug products in sufficient quantities to support preclinical, Investigational New Drug (IND)-enabling, and clinical studies. Services include designing, developing, manufacturing, and releasing drug products, including clinical trial materials, precursors, reference standards, and all necessary testing. Ancillary materials such as placebos, diluents, adjuvants, master cell banks, and testing standards may also be required to support clinical and regulatory activities. The scope covers activities across a broad spectrum of product formats, including small molecules, biological molecules, gene therapy vectors, nanoparticles, and potentially novel or modified formats, as well as devices or combination products. All activities must adhere to current Good Manufacturing Practice (cGMP) standards, with preliminary activities like formulation studies and development lots also included. The contract emphasizes maintaining materials in a usable state through storage, shipping, testing, and documentation to facilitate regulatory submissions. The work is performed primarily in Rockville, Maryland, with the opportunity to support a wide range of project sizes, complexities, and durations, ensuring flexibility to accommodate evolving therapeutic formats and manufacturing needs.

General Info

Contract for chemistry, manufacturing, and control services for drug products supporting clinical studies.

Agency

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

NAICS

325412 - Pharmaceutical Preparation Manufacturing

Place of Performance

Rockville, MD, 20850, USA

Set-Aside

NONE

Documents

Additional Business Proposal Instructions Template

18 pages · sow

High

Amendment 1 to RFP 75N95025R00005

2 pages · amendment

High

Amendment 2 to RFP 75N95025R00005 - Questions and Answers

2 pages · amendment

High

Attachment 3 - Ramp-On TRND 3 SOW - CMC DP (8/23/24)

7 pages · sow

High

Attachment 7 - Additional Technical Proposal Instructions

16 pages · sow

High

Attachment 9 - Technical Proposal Cost Information/Summary of Labor and Direct Costs

1 page · sow

High

CMC Drug Product Sample Task Order for Technical Area 2 (Peptides and Oligos)

7 pages · task-order-request-for-proposals

High

CMC Drug Product Sample Task Order for Technical Area 3

5 pages · sow

High

NIH eCPS Attachment 1: Packaging and Delivery of Proposals

2 pages · sow

High

NIH Invoice Instructions for Fixed-Price Contracts (NIH(RC)-2)

3 pages · specifications

High

NIH(RC)-1 Exhibit A: NIDA Supplemental Billing Instructions

1 page · specifications

High

NIH Supplier Qualification Questionnaire Supplemental Questions for Sterile Drug Suppliers

1 page · questionnaire

High

RFP 75N95025R00005 - Chemistry, Manufacturing and Controls Services

82 pages · rfp

High

Sample Task Order for Technical Area 1 (Small Molecule)

7 pages · task-order-rfp

High

Section K Reps and Certs - Attachment 17

11 pages · reps-and-certs

High

Attachment 10 - Summary of Related Activities

1 page · supporting-document

Low

Attachment 11 - FAR Clause Deviation Acknowledgement

1 page · acknowledgement-form

Low

Attachment 15 - Offeror's Points of Contact

1 page · other

Low

Attachment 16 - Disclosure of Lobbying Activities

1 page · other

Low

Attachment 25 - Questions and Answers/Clarifications

3 pages · q-and-a

Low

Breakdown of Proposed Estimated Costs Plus Fee

25 pages · cost-proposal-template

Low

CMO Supplier Audit Questionnaire

10 pages · questionnaire

Low

General Clauses for Cost-Reimbursement Contract

14 pages · contract-document

Low

NIH 1688-1 Project Objectives Form

1 page · other

Low

NIH-2043 Proposal Summary and Data Record - RFP 75N9502 5 R000 05

2 pages · proposal-summary

Low

NIH Clinical Center Pharmacy Quality Agreement

19 pages · contract-document

Low

NIHRC-1 Invoice/Financing Request Instructions

7 pages · specifications

Low

RFP 75N95025R00005 Proposal Intent Response Form

1 page · rfi

Low

AI Contract Breakdown

Uniform Contract Format

Contract not broken down yet

CLEATUS splits the solicitation into Uniform Contract Format (UCF) sections: scope, pricing, deliverables, and evaluation criteria.

Timeline

2 updates

PhaseClosed

PostedNov 30

Combined Synopsis

Notice updatedDec 20

Notice details unchanged. Attachments may have changed.

Notice updatedJan 14

Notice details unchanged. Attachments may have changed.

Response DeadlineFeb 3

Deadline has passed

Submission Closed

02/03/2025, 08:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health Nida

Contacts2 people available

OfficeBethesda, MD, 20892, USA

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Nida

Office AddressBethesda, MD, 20892, USA

Contacts

Michelle Cecilia

Valerie Whipple

Full Description

The Therapeutic Development Branch (TDB) within the Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research in the area of human therapeutics development. The scope of this contract is for Chemistry, Manufacturing, and Control (CMC) services for Drug Products. The objective of these support services is to ensure receipt of formulated Drug Product (DP) of sufficient quality and quantity to support preclinical, IND-enabling and clinical studies. The Contractor shall provide support for a broad range of preclinical services required for the design, development, manufacture, and release of DP, and release of DP as Clinical Trial Material (CTM), including precursors, preliminary states, Reference Standards (RS) and all required testing. Ancillary products (e.g., placebos, diluents, adjuvants, master cell banks, testing standards, reference materials) and other materials manufactured or purchased to support clinical trials or CMC activities may also be required. All activities preliminary to manufacturing in accordance with current Good Manufacturing Practice (cGMP) may be required (e.g., development or engineering lots, formulation studies), even without an associated cGMP manufacturing task. All activities required to maintain material in a usable state, including storage, shipping, testing (in process, release, stability, and quality actions), and preparation of documents to support regulatory submissions may also be required. Product formats may include small molecules, short oligomeric compounds, biological (large) molecules, quaternary molecular assemblies (homogenous or heterogenous), vectors for gene therapy, nanoparticles, and any of the above modified genetically, biologically, or chemically. Novel formats identified after this draft might also be needed. Formats could also include Devices or Combination Products. The breadth of this Statement of Work (SOW) includes capabilities to support a range of activities differing in size, complexity, and duration. All applicable attachments in connection with this solicitation are available for download.