Pharmacokinetic Analysis Resource Center

The National Institute on Drug Abuse (NIDA) is seeking capability statements from small businesses having in-house capability to provide pharmacokinetic resources in support of the pharmacokinetic (PK) and pharmacodynamics (PD) aspects of the medications development. No actual clinical or laboratory studies will be carried out under this contract. The Contractor shall prepare study protocols, monitor clinical studies to assure that pertinent FDA regulations are met, perform data management and process clinical and pharmacokinetic data, conduct PK, PD, and statistical analyses, and prepare study reports.The data/reports will be submitted to the FDA in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications). Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous similar projects, specific experience in providing support for PK/PD studies and work in the field of drug abuse; (2) Personnel: Name, professional qualifications and specific experience of scientists and/or technical personnel who may be assigned as project director and other key positions; (3) Facilities: Availability and description of facilities and equipment required to conduct this type of work. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. Small business concerns that believe they possess the capability necessary to successfully undertake the work described above should submit an electronic copy of their capability work statement and must provide the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice, and 7) type of small business your organization classifies itself as (i.e.: women-owned, HUBZONE, etc.). Written capability statements must be RECEIVED NO LATER THAN June 27, 2018 by 3 pm and emailed to the Contracting Officer at contact@example.gov. Disclaimer and Important Notes: This notice is for informational purposes and does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).