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A--A -- Notice of Intent to Sole Source to University of New Mexico, College of Pharmacy

Notice Date
Notice Type
Solicitation Notice
Contracting Office
Attn: Department of Veterans Affairs New Mexico Health Care System, (501/90C), 1501 San Pedro Drive SE, Albuquerque, New Mexico 87108
ZIP Code
Solicitation Number
Response Due
Archive Date
Small Business Set-Aside
The New Mexico Veterans Affairs Health Care System (NMVAHCS), located in Albuquerque, New Mexico, intends to negotiate a sole source contract with University of New Mexico (UNM) College of Pharmacy, 2502 Marble NE, Albuquerque, NM on behalf of the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (VA CSPCRPCC) to provide custom product development work for various research products to be undertaken by the VA CSPCRPCC. The contract period will be for a base period of 1 year, plus 4 option years. The work frequently requires immediate availability by UNM Pharmacy employees (within 30 minutes) to the Albuquerque, NM manufacturing site in the event problems occur during the manufacturing or testing process that, without immediate attention, could result in the loss of expensive research materials. This contract will cover the research and development of formulations and manufacturing processes for various drug products and placebos which will be manufactured to meet the specific needs of various Cooperative Studies Program (CSP) clinical trials. The following describes the types of work that will be performed by the formulation specialist as part of the development of drug products and placebos: Conduct literature reviews and evaluate the available information regarding research projects, Characterize the powder and chemical properties of the active pharmaceutical ingredients including particle size, morphology, density and flow, Screen excipients and Active Pharmaceutical Ingredient to determine compatibility with raw materials, manufacturing equipment contact surfaces (stainless steel, etc), and finished dosage form (capsule shell, coating, etc), Based on data obtained, select appropriate excipients and develop formulations for the active drug products and placebos, which include the quantities of the active and excipient ingredients required to manufacture the required batch sizes, Develop manufacturing methods, Develop calculations to allow scaling the batch sizes to larger or smaller equipment and conduct experiments, where appropriate, with the equipment being used for scaling, Prepare laboratory-scale batch(es) prior to actual production to verify the product formulation, Prepare and provide test samples to the analytical laboratory to use for transferring the analytical methods and establishing short term stability, Prepare manufacturing records, Be available to provide formulation services on short notice (i.e., conduct and complete formulation development within 1 to 4 weeks of notification date) as compared to normal industry expectations (6 to 16 weeks), Train and advise center employees on the formulation requirements and manufacturing procedures, Review procedures, manufacturing processes, laboratory results (blend uniformity), potency, content uniformity, dissolution/disintegration, and/or stability, and establish specifications to identify necessary changes for subsequent production batches, Document changes to manufacturing procedures and update manufacturing records, Prepare reports, Assist in manufacture of active and placebo product, Assist in investigations of manufacturing or analytical process problems, Conduct new employee training and basic training on considerations in formulation development for all CSP employees. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTES. No solicitation document is available and telephone requests will not be accepted. However, any firm that believes it can meet the requirements may give written notification to the Contracting Office within 10 calendar days from the date of publication of this synopsis. Supporting evidence must be furnished in sufficient detail to demonstrate the ability and qualifications of the firm to provide these services. If no responses are received, the NMVAHCS will proceed with the sole source negotiation with University of New Mexico, College of Pharmacy. NAICS Code: 541710, Size Standard is 750 employees.
Place of Performance
Address: VA Cooperative Studies Program, 2401 Centre Avenue SE, Albuquerque, NM
Zip Code: 87106
Country: United States
SN01146736-W 20060920/060918220357 (fbodaily.com)
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