Notice ID
90c04c65c09aa732941f99c8d738849b
The Pharmaceutical Resources Branch of the Developmental Therapeutics Program Division of Cancer Treatment Diagnosis and Centers National Cancer Institute NCI is seeking a contractor experienced in analysis and evaluation of clinical pharmaceuticals to provide testing and evaluation of shelf life samples of investigational clinical drug formulations including both injectable products and oral dosage forms and report the results of such testing Data in these reports will provide NCI and its investigators with information regarding the proper storage and handling of various drug products under investigation for determining appropriate expiration dates for the products and to support NCIs Investigational New Drug Applications INDs files with the Food and Drug Administration FDA The Contractor will be responsible for evaluating each of the analytical methods in compliance with FDA requirements prior to use Currently there are approximately 100 lots of NCI drug products on stability testing It is anticipated that there will be 10 to 15 new chemical entities each year requiring analytical method evaluation and shelf life determination These will require approximately 150 separate evaluation per year The NAICS Code for this acquisition is 54171 It is anticipated that one Performance Based contract will be awarded for a five 5 year period The proposed contract project represents a recompetition of Contract N02CM7701328 The solicitation is scheduled for electronic release on or about August 30 2001 The RFP may be accessed through the Internet at httprcbncinihgov It is the offerors responsibility to monitor the above Internet site for solicitation release and any amendments POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS No collect calls will be accepted
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