Development & Manufacture of Oral & Topical Dosage Forms

The Pharmaceutical Resources Branch (PRB), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking a Contractor to furnish services for development, manufacture, analysis, packaging and labeling of pharmaceutically acceptable oral and topical dosage forms of new anticancer agents in support of NCI-sponsored clinical trials. The incumbent is University of Iowa (NCI Contract No. NO2-CM-52200). The most common dosage forms will include capsules, tablets, enteric-coated tablets, ointment and cream. The Contractor will perform formulation and process development, manufacture and controls, packaging and labeling of oral and topical drug products to be used in clinical trials. Batch sizes will range from very small batches required for toxicology studies (e.g. 100s of capsules), to larger batches required for Phase II clinical trials (e.g. several thousand capsules or tablets). Data obtained from the Contractor will be used to prepare IND application to submit to the FDA. The Principal Investigator should have at least three years of experience in the development and manufacturing of pharmaceutical dosage forms. Other personnel should possess suitable training and experience to insure satisfactory performance of the contract. The facilities and equipment must be adequate to develop, manufacture and quality control of oral and topical dosage forms. The facilities should also have adequate air-handling systems to be suitable for handling highly cytotoxic agents. It is anticipated that one funded contract will be awarded for a period of five (5) years plus two (2) options years for a potential period of performance for seven (7) years. NAICS code No. 325412 with a size standard of 750 employees. The potential award is one hundred percent (100%) small business set aside. The solicitation is scheduled for electronic release on or about June 22, 2009. An Offeror must meet a mandatory qualification criterion which requires the Contractors to be a FDA approved manufacturer, must have facilities to handle cytotoxic agents and the Offerors' manufacturing facilities must be in compliance with current good manufacturing practices (cGMP) set forth by the FDA. The RFP may be accessed through Internet at: IT IS THE OFFEROR'S RESPONSIBILITY TO MONITOR THE INTERNET SITE FOR THE RELEASE OF THIS SOLICITATION AND AMENDMENTS, if any. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. ALL QUESTIONS MUST BE IN WRITING. Point of Contact: Marrita Murphy at murphymar@mail.nih.gov FAX: 301-402-4240; Telephone 301-401-4218. No collect calls will be accepted.