Senior Regulatory & Quality Consultation - CBRND and Emerging Infectious Disease Support

This is a Sources Sought Notice (SSN) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this SSN. This notification is being issued in accordance with FAR Part 10, Market Research. The U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division, on behalf of the Joint Program Executive Office for Chemical, Biological, Radioactive and Nuclear Defense (JPEO-CBRND) is seeking sources and information on the capabilities and willingness of companies to to provide expert regulatory and quality support for the tasks similar to those stated below: Fostering the development of medical products to approval by the U.S. Food and Drug Administration. Researching and reporting on medical product development laws and regulations Developing and commercializing drugs, vaccines, biologics, diagnostics, and or medical devices. Achieving product approval with complex regulatory strategies that involve orphan drugs, rare diseases, new mechanisms of actions, vaccines, and animal rules. Reviewing test data to determine alignment with target product profiles and regulatory strategies Analyzing and providing feedback on clinical practice guidelines Performing independent technology readiness level assessments, FDA safety and efficacy assessments and, Chemistry, Manufacturing, Controls (CMC) assessments. Reviewing and provisioning recommendations for Target Product Profiles and Regulatory Strategies. Developing, providing input and advisement to documents (IB, Protocol) required for complete submission packages to the FDA. This includes table of contents (TOCs), summary sections (CTD, eCTD) and a draft cover letter. Coordination of team/IPT comments, and meetings for comment resolution. Designing and implementing human clinical trials for medical product safety and efficacy assessments at all phases of clinical development and post-market. While this notice is not a request for competitive proposals, parties purporting to have the requisite capabilities to provide the support services must furnish, in writing, factual information for the following points: A capabilities overview which explains your company's ability to provide expert level regulatory consultants to support Government efforts such as those stated above. A description of prior projects or contracts that are similar in complexity to the sample tasks stated above. Include your company size, CAGE and DUNS in your response. All questions regarding this notice must be in writing only. Information received in response to this notice may be used in support of future acquisitions. The Government will retain comments and information received in response to this SSN and is not obligated to respond to submissions. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. Responses should not exceed five pages in length, should have the notice number, organization name and RFI title in the email subject line and should be sent to susan.e.ruzicka2.civ@mail.mil no later than the time and date of this announcement.