Inactive

DESCRIPTION: This notice is for market research purposes only and does NOT constitute a Request for Proposal (RFP). This notice shall not be construed as a contract, a promise to contract, or a commit... DESCRIPTION: This notice is for market research purposes only and does NOT constitute a Request for Proposal (RFP). This notice shall not be construed as a contract, a promise to contract, or a commitment of any kind by the government. The government is NOT seeking or accepting unsolicited proposals. This notice is issued solely for conducting market research in accordance with FAR Part 10 and gathering information for planning purposes. The government WILL NOT PAY for any information received in response to this notice. The government will not compensate the respondent for any cost incurred in developing the response to this notice. Without written permission, the government will not release any proprietary information in response to this notice to any firms, agencies, or individuals outside the government. Please be advised that all submissions become government property and will not be returned. Phone calls will not be accepted. SUMMARY: This Sources Sought notice is being issued by the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), through Army Contracting Command – Aberdeen Proving Ground (ACC-APG), Natick Contracting Division (NCD), to conduct Market Research in accordance with FAR Part 10. The government requires a subject matter expert to provide services necessary to evaluate manufacturing processes and review deliverables to assist in the development of auto-injector products, including associated Food and Drug Administration (FDA) regulated activities. The government requires a subject matter expert to provide medical device expertise in reviewing design control documentation, regulatory device documentation, evaluating design team performance and evaluating engineering systems input and output for device manufacture and development. The government requires a subject matter expert with in-depth knowledge of combination products, specifically auto-injector manufacturing, and development, to include the following: - Device development - Design for Six Sigma - Device reliability - Engineering design and drawings - Manufacturing process development - Component development - molding processes - Cartridge fill/finish and primary container closure systems The government requires a subject matter expert with working knowledge of Design History Files, inclusive of legacy products being updated to current Good Manufacturing Practice (GMP) standards, as demonstrated in both previous experience and training courses. The government requires a subject matter expert familiarity and experience evaluating manufacturing processes using all International Standards Organization (ISO) and American Society for Testing and Materials (ASTM) standards related to combination products (e.g., ISO standards 7886-1, 10993-1, 11608 (all parts), 10993-1, 13485, and 14971; ASTM D4169; etc.). The government requires a subject matter expert familiarity with FDA guidance for industry (e.g., “Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products”; Class II devices under 21 Code of Federal Regulations (CFR) 880.5860 < tel:880.5860 > and 21 CFR 880.6920 < tel:880.6920 >; etc.). The government requires a subject matter expert with experience evaluating feedback and preparing submissions for the FDA review centers involved in the approval of combination products, particularly the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH). The government requires a subject matter expert experience with relevant risk assessment and problem-solving techniques (e.g., Failure Mode Effects Analysis (FMEA), fault trees, root cause analyses, etc.). A copy of the Performance Work Statement (PWS) is provided for informational purposes only. INFORMATION REQUESTED: Responses are not to exceed five (5) pages. Responses shall be in electronic format. Please provide the following information: Name and address of company Company point of contact – name, phone, and email address Business Size Status for the North American Industry Classification System (NAICS) code of this notice (e.g. large, small, 8(a) program, small disadvantaged business, woman owned, etc.) Parent company, potential teaming partners, prime contractor (if potential subcontractor) or subcontractors (if potential prime contractor). List of customers covering the past five years (highlighting relevant work performed, contract numbers, contract type, and dollar value of each procurement) Experiences that are applicable to the scope of the PWS SUBMISSION: The government will accept only electronic unclassified submission of responses. Responses shall be sent to Contract Officer, Mr. Andrew Richard (andrew.j.richard12.civ@army.mil) and Contract Specialist, Jason Papadopoulos (jason.g.papadopoulos.civ@army.mil) with the subject line Sources Sought – Notice ID #. All responses shall be unclassified and submitted no later than 5:00PM Eastern Standard Time on 14 March 2023.