VERSITI BLOOD HEALTH, INC.

No reported sub-awards as a subcontractor.

• COMOTION DRUG DELIVERY SYSTEMS INC.

  UEI UDFLYUNDFCN9 · not in the directory yet

  $900K

  Subcontracted by this company · 1 sub-award · latest Oct 18, 2024

  • Defense Health Agency
  • “MAJOR TASK 2.1: GENERATE ANALYTICAL AND BIOANALYTICAL METHODS FOR THROMBIN AND TXA ASSESSMENT. SUBTASK 2.1.1: DEVELOP METHODS TO TXA AND THROMBIN ANALYSIS IN COUNTERFLOW-GAUZE. MILESTONE #2.1: TXA AND THROMBIN ANALYSIS METHODS FOR COUNTERFLOW-GAUZE DEVELOPED AND VALIDATED. MAJOR TASK 3.3: SUBMISSION OF IDE/IND APPLICATION. SUBTASK 3.3.2: PREPARE AND SUBMIT A FORMAL REQUEST FOR DESIGNATION (RFS) TO FDA. MILESTONE #3.7: OBTAIN DECISION LETTER FROM THE FDA WITH OFFICIAL DESIGNATION OF COUNTERFLOW-GAUZE. SUBTASK 3.3.2: PREPARE A PRE-IDE/IND MEETING INFORMATION PACKAGE, AND CONDUCT A PRE-IDE/IND MEETING WITH THE FDA TO OBTAIN FEEDBACK ON DATA FROM SUBTASKS 3.11 AND 3.2.1 AND DETERMINE IF REVISIONS TO THE EXPERIMENTAL DESIGN FOR SUBSEQUENT SUBTASKS ARE NEEDED. MILESTONE #3.8: RECEIVE CONFIRMATION FROM THE FDA TO REVISE AND/OR COMPLETE THE REMAINDER OF TOXICOLOGY STUDIES IN OBJECTIVE 3. SUBTASK 3.3.3: PREPARE A DRAFT IED?IND APPLICATION WHICH SUMMARIZES ALL PRECLINICAL ANIMAL DATA AND MANUFACTURING INFORMATION AND OBTAIN FEEDBACK FROM THE FDA THROUGH A FOLLOW-UP PRE-IDE/IND MEETING. MILESTONE #3.9: SUBMISSION OF IDE/IND TO THE FDA. MAJOR TASK 4.1: ESTABLISH GMP MANUFACTURING, WITH APPROPRIATE CMC, AND PRODUCE A PILOT BATCH FOR GLP SAFETY TESTING AND EVENTUAL CLINICAL TESTING. SUBTASK 4.1.1: PROJECT PLAN FOR ESTABLISHING MANUFACTURING AT EXTERNAL SUPPLIER. SUBTASK 4.1.2: UPGRADE EXISTING EQUIPMENT AT EXTERNAL SUPPLIER. MILESTONE #4.1: PRODUCE AN ASSAY DEMONSTRATION BATCH AT EXTERNAL SUPPLIER. SUBTASK 4.2.1: ESTABLISH PROCESSES AND INFRASTRUCTURE FOR WELDING BARIUM THREAD TO GAUZE FABRIC. SUBTASK 4.2.2: UPGRADES AND RETROFIT EXISTING LYOPHILIZATION EQUIPMENT FOR HIGH-THROUGHPUT LYOPHILIZATION. MILESTONE #4.2: QUALIFICATION OF PROCESSES AT MDS. MILESTONE #4.3: PILOT BATCH OF COUNTERFLOW-GAUZE OF UP TO 2.4K UNITS MANUFACTURED UNDER GMP CONDITIONS TO SUPPLY GLP STUDIES.”

Agencies generally may not award to excluded parties, and primes may not subcontract with them above the threshold in FAR 52.209-6 (except COTS items) without a compelling reason reported to the contracting officer (FAR 9.405, 9.405-2). Some exclusion types apply only to specific programs: read the record on SAM.gov.