Top

Vehicle Recompete: CRO SUPPORT FOR NCATS REGULATORY AFFAIRS AND RELATED SERVICES — INDEFINITE DELIVERY / INDEFINITE QUANTITY 75N95021R00008

Active

Federal

Contract Overview

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

AI Contract Overview

This indefinite delivery, indefinite quantity contract provides contract research organization support for regulatory affairs and related services for the National Institutes of Health. The vehicle, which has an ordering period extending through June 9, 2027, is currently classified as a full recompete. There are currently seven active task orders with a combined total value of 1,107,403.33 dollars. Two companies currently hold orders under this vehicle, with CCS Associates, Inc. managing four orders totaling 741,425.07 dollars and MPF Federal, LLC managing three orders totaling 365,978.26 dollars. Primary activities focus on regulatory support for gene therapy candidates and the preparation of Investigational New Drug and Pre-Investigational New Drug applications with the Food and Drug Administration for various treatments, including those for Jansen's Metaphyseal Chondrodysplasia and Congenital Myasthenic Syndromes.

General Info

NIH IDIQ for regulatory affairs support through 2027, valued at 1,107,403.33 dollars.

Agency

Department Of Health And Human Services → National Institutes of Health

NAICS

541690 - Other Scientific and Technical Consulting Services

Place of Performance

Not specified

Set-Aside

NONE

Documents

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

Uniform Contract Format

No documents to break down

The breakdown needs solicitation documents. None were found from this contract's source.

Timeline

1 update

PostedDec 9

pre-forecast

Notice updatedDec 9

The notice description changed.

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

AgencyDepartment Of Health And Human Services → National Institutes of Health

ContactsNo contacts available

OfficeN/A

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

Office AddressN/A

ContactsNo contact information available

Full Description

CRO SUPPORT FOR NCATS REGULATORY AFFAIRS AND RELATED SERVICES (INDEFINITE DELIVERY / INDEFINITE QUANTITY) — vehicle 75N95021R00008 ordering period ends 2027-06-09T00:00:00.000Z. 7 active task orders valued at $1,107,403.33.
3 awards under one solicitation: 75N95022D00013, 75N95022D00014, 75N95022D00015 Original Solicitation: 75N95021R00008 Agencies: National Institutes of Health Classification: full-recompete (Confidence: high - 85/100)
Incumbents (2 companies hold orders on this vehicle): - CCS ASSOCIATES, INC.: $741,425.07 across 4 orders - MPF FEDERAL, LLC: $365,978.26 across 3 orders
Top task orders by value: - PREPARATION OF AN INVESTIGATIONAL NEW DRUG (IND) APPLICATION WITH FOOD AND DRUG ADMINISTRATION (FDA) FOR A TREATMENT FOR JANSEN'S METAPHYSEAL CHONDRODYSPLASIA ($240,897.48) - CCS ASSOCIATES, INC. - NEW SOW FOR REGULATORY ACTIVITIES FOR PCCA AND MMAB GENE THERAPY PRODUCTS ($230,616.68) - CCS ASSOCIATES, INC. - REGULATORY SUPPORT FOR LEAD GENE THERAPY CANDIDATES AS A TREATMENT FOR ORGANIC ACIDEMIAS, PROPIONIC ACIDEMIA (PA) AND METHYLMALONIC ACIDEMIA TYPE B (MMAB) ($178,885.25) - MPF FEDERAL, LLC - REGULATORY SUPPORT FOR LEAD GENE THERAPY CANDIDATES AS A TREATMENT FOR CONGENITAL MYASTHENIC SYNDROMES ($159,115.55) - CCS ASSOCIATES, INC. - REGULATORY SUPPORT FOR PREPARATION AND FILING OF A PRE-INVESTIGATIONAL NEW DRUG (PRE-IND) APPLICATION WITH THE FOOD AND DRUG ADMINISTRATION (FDA) FOR CLINICAL DEVELOPMENT OF MITRAGYNINE (MG). ($110,795.36) - CCS ASSOCIATES, INC.