REQUEST FOR QUOTATION (RFQ) for LC-MS & HPLC
PROCUREMENT NO. PQM+_05212024_LC-MS_HPLC
SECTION 1.0 - RFQ OVERVIEW
1.1 The United States Pharmacopeial Convention, Inc. (USP)
The United States Pharmacopeial Convention, Inc. (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. Since 1992, the United States Agency for International Development (USAID) and USP have collaborated to help address critical issues related to the access of quality medicines.
The USAID Cooperative Agreement No. 7200AA19CA00025 entitled “Promoting the Quality of Medicines Plus (PQM+) program” is a six-year (September 27, 2019 – September 26, 2025) USAID-funded cooperative agreement with a goal to sustainably strengthen medical product quality assurance (QA) systems in low-and middle-income countries. PQM+ provides technical assistance (TA) to build in-country capacity of medical products regulatory authorities’ QA systems in assisted countries. PQM+ also provides technical support to manufacturers of quality- assured priority medical products for malaria, tuberculosis (TB), neglected tropical diseases, other infectious diseases, family planning and reproductive health, and maternal, newborn, and child health.
1.3 RFQ Purpose and Objective
As outlined in Attachment A – Scope of Work (SOW)/Specifications, PQM+ seeks quotes from a pharmaceutical/medical equipment supplier to provide cost and pricing for one (1) unit LC-MS, one (1) unit of HPLC and other accessories. Refer to Attachment A for a complete specifications/scope of work.
The shipping address is: Chemical Process Technology (CPT, at 45 Battery Street, Waltloo, Pretoria, 0184, South Africa.
SECTION 2.0 – RFQ PROCEDURES AND INSTRUCTIONS
This section of the RFQ provides the general procedures and instructions the offeror is expected to follow in completing its response.
2.1 Proposal/Quotation Contents
Offeror shall include the following with its proposal/quotation:
2.1.1 Offer Letter – prepared on the Offeror’s letterhead, signed, and dated by an authorized official who has the authority to sign and legally bind the Offeror. Include offeror name, date of offer, price, quote validity period, name, and title of the signing official. The Offer Letter must include acceptance of “Other RFQ Requirements” detailed in the SOW.
2.1.2 Cost Offer – using Attachment A, provide a fixed price quote using Pretoria, South Africa as the delivery point. Quote shall include at a minimum:
a) All cost and pricing associated with Seller’s responsibilities, CIP INCOTERMS to fulfill the entire order, pack cargo in entirety conforming to export packaging, loading charges, deliver from seller location to O.R. Tambo International Airport of Johannesburg, South Africa, and clear customs from country of origin in full (including any associated country of origin export duty, taxes, handling charges, and customs clearance costs, etc). and/or DDP INCOTERMS to fulfill the entire order including packing, loading, shipment, handling, exporting, customs clearance etc. at both country of origin and country of recipient with door delivery to Chemical Process Technology (CPT) located at 45 Battery Street, Waltloo, Pretoria, 0184, South Africa.
b) Provide quotes for both air and sea transport (separate quotes). If air transport requires any items of the order to be separately shipped, so state and price.
c) Include equipment installation costs including IOPQ documentation, if applicable.
d) Training – provide pricing per Exhibit A.
e) Include 3 years of service pricing in the quote per Exhibit A.
2.1.3 Proof of Insurance – using Attachment A, provide proof of commercial liability insurance that demonstrates coverage for the amount of the cost cited in 2.1.2 and is suitable to the size, scope, and complexity of the equipment in Attachment A.
2.1.4 Small business concern – if the Offeror has a small business concern designation, please provide the U.S. Small Business Administration designation and/or NAICS, the SAM.gov assigned universal entity identification (UEI) No., or name of certifying agency and date of expiration.
2.1.5 Documentation – Offeror must include in the quotation
a) Seller INCOTERMS conforming to 2.1.2 as stated
b) Cite FAT and SAT qualification documents in the quote with $0 price
c) Any other qualification process instructions
d) Preventive maintenance and service requirements
e) Warranty coverage for quoted equipment and
f) Business Registration.
2.1.6 Service pricing - include service contract pricing after the first year through the useful life of the equipment as supplemental information (not part of this RFQ but the information is necessary for the beneficiary).
2.2 Period of Performance
For pricing purposes, assume an anticipated order date of June 17, 2024.
2.3 Quote Validity Period
Offeror’s quote shall be considered valid for Ninety (90) days after submission.
2.4 Third Party Services/Products
Offeror must clearly identify any third-party product(s) or service(s) that is a part of its RFQ response. If applicable, Offeror must state that it is licensed to use any such product(s).
2.5 Anticipated Agreement Type
It is anticipated that a fixed price contract will be issued. Applicable flow-downs from USP and USP’s Client will be included as cited in the SOW. USP reserves the right to terminate the resultant contract if deliverable and specification targets are not met. The selected supplier will be required to provide USP/PQM+ with proof of insurance naming USP/PQM+ as additional insured upon completion of the sourcing process.
2.6 Prevailing Language
All documents submitted in response to this RFQ, as well as all correspondence in connection with the RFQ, shall be in the English language.
SECTION 3.0 RFQ EVALUATION PROCESS AND SCHEDULE
3.1 Schedule
The proposed RFQ schedule is below. If necessary, USP may modify in writing.
Activity
Deadline
RFQ Issued
May 21, 2024,
Questions submitted by interested Offerors
May 24, 2024,
RFQ Responses Due
June 04, 2024, 5:00 PM EST
Notice of selected Offeror
June 14, 2024,
3.2 Evaluation Criteria
Offeror responses may be evaluated on criteria such as but not limited to the factors below. USP reserves the right to make a selection based on the proposal offering best value based on multiple evaluation factors. Completeness of quotation, technically acceptable, price, and delivery timeline.
SECTION 4.0 RFQ CORRESPONDENCE
4.1 RFQ Questions
RFQ questions shall be submitted on the date in 3.1 to GPH_Procurement@USP.org and Masoud.Azam@USP.org.
4.2 Notifications
Offerors will be notified via email if their quote is within competitive range. The selected offeror (if any) will be notified via email of the results of the selection process. Precise delivery information will be provided to the selected offeror (if any) following the selection process.
SECTION 5.0 - RFQ TERMS AND CONDITIONS
5.1 Related Incurred Costs
The offeror shall be responsible for all costs incurred in preparing or responding to this RFQ. All materials and documents submitted in response to this RFQ become the property of USP and will not be returned. This RFQ will in no way obligate USP to compensate any offeror for costs associated with the preparation of its proposal.
5.2 Reservation of Rights
This RFQ does not commit USP to make a selection as a result of this RFQ, award a contract, to pay any costs incurred in the preparation of a proposal/quote to this request, or to procure services or supplies. USP reserves the right to cancel this procurement at any time without prior notice. USP may require the offeror to participate in discussions, and to submit such cost or other revisions of their offer that may result from such discussions.
All information contained in this RFQ is proprietary. It is for the sole use of the Offeror in connection with this RFQ and is not to be used by Offeror for any other purpose or revealed or disclosed in any manner to any other individuals and/or company without specific written permission from USP.
5.3 Rejection of Solicitation Response
USP reserves the right to reject any or all responses received or any part thereof, to accept any response or any part thereof, or to waive any informalities when it is deemed to be in USP’s best interest.
5.4 Confidential Information
Materials submitted by Offeror in response to the RFQ that are considered confidential/proprietary
must be clearly marked as such at the time of submission.
5.5 Responsibility for Compliance with Legal Requirements
The offeror’s products, services, and facilities shall be in full compliance with all applicable federal, state, and local laws, regulation, codes, standards, and ordinances, regardless of whether or not they are referred to by USP.
5.6 No Publicity
No publicity or new release pertaining to this RFQ, responses to this RFQ, USP’s decision regarding Offeror selection, or the award of any resultant contract as a result of RFQ submission may be released without USP’s express prior written consent.
5.7 Compliance Requirements
By submitting an Offer to this RFQ, Offeror confirms understanding that the quoted equipment cost and pricing will be provided to USP/PQM+ and is subject to Client policies, terms and conditions if selected as the successful Offeror.
Upon selection (if any), Offeror will be required to submit a certificate of insurance naming USP as additional insured on applicable policy(ies) for the duration of any contract and associated purchase order resulting from the RFQ.
The selected Offeror, if any, will be required to provide the Bill of Lading, Certificate of Origin, Packing List, and any other documentation required for customs clearance in South Africa or for order receiving by USP/PQM+ and the beneficiary manufacturer.
Offeror agrees that it understands that if selected and approved by USP’s and USP’s Client, final negotiated costs are contingent upon approval of USP’s Client and availability of funds. If approved, the successful Offeror, if any, will enter into a contract with USP, which will include standard terms and conditions and USP Purchasing Terms and Conditions located https://www.usp.org/legal-notices/purchasing-terms and https://www.usp.org/legal-notices/purchasing-terms/donor-funded-requirements.
ATTACHMENT A – SCOPE OF WORK (SOW)
The Offer shall provide a quote and detail in accordance with the terms and conditions of the RFQ and the scope specifications detailed in this Attachment A.
1- One (1) Liquid Chromatography – Mass Spectrometry (LC-MS) meeting the specifications listed below.
Specifications for LC-MS
Quote should include the following deliverables
· Provide all documentation: operational manuals, maintenance, etc.
Vendor or distributor technical representation in South Africa preferred for potential future service need.
2- One (1) HPLC meeting the specifications listed below.
Specifications for HPLC
Quote should include the following deliverables
· HPLC meeting specifications as listed above
· Provide all documentation: operational manuals, maintenance, etc.
· Include installation qualification, operational qualification, software validation as per the pharma requirements and training of personnel at the workplace of end user.
· Training for three personnel. Training should be in English, length of the training to be specified by the vendor.
· A 3-year complete SLA, covering all parts and labor and includes a yearly preventative maintenance. Also include priority response during this period.
Vendor or distributor technical representation in South Africa preferred for potential future service need.
1.1 The United States Pharmacopeial Convention, Inc. (USP)
The United States Pharmacopeial Convention, Inc. (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. Since 1992, the United States Agency for International Development (USAID) and USP have collaborated to help address critical issues related to the access of quality medicines.
1.2 PQM+ Project Overview
The USAID Cooperative Agreement No. 7200AA19CA00025 entitled “Promoting the Quality of Medicines Plus (PQM+) program” is a six-year (September 27, 2019 – September 26, 2025) USAID-funded cooperative agreement with a goal to sustainably strengthen medical product quality assurance (QA) systems in low-and middle-income countries. PQM+ provides technical assistance (TA) to build in-country capacity of medical products regulatory authorities’ QA systems in assisted countries. PQM+ also provides technical support to manufacturers of quality- assured priority medical products for malaria, tuberculosis (TB), neglected tropical diseases, other infectious diseases, family planning and reproductive health, and maternal, newborn, and child health.
