Health Commodity Testing Services

REQUEST FOR QUOTATION
Solicitation Title: Health Commodity Testing Services
Solicitation Number: FHI 360-FY26-002-QC Testing
Submit Questions and Quotation to: PQCProcurement@fhi360.org
Date of Issue of RFQ: Monday, May 18, 2026
Date Acknowledgement Form (Intent to Bid) Due: Friday, May 29, 2026, 5pm EDT
Date Questions from Supplier Due: Friday, May 29, 2026, 5pm EDT
Date Answers due from FHI 360: Monday, June 8, 2026
Date Proposal Due: Friday, June 26, 2026, 5pm EDT
Approximate Timeframe Vendor Agreement Issued to
No later than August 2026
Successful Candidate(s):
Method of Submittal:
Respond via e-mail with attached document in MS Word / pdf /Excel format. Pricing should be
provided in Excel format unless otherwise specified.
Quote Validity:
The Consultant agrees to hold the prices in its offer firm for 3 years from the date specified for the
receipt of offers unless another time is specified in the addendum of the RFQ (unless noted in Cost
Quotation).
Term of Contractual Agreement:
Term of Purchase Order/Contractual Agreement will be 3 years. If pricing cannot be held firm,
provide an escalation schedule.
Attachments:
Attachment A: FHI 360-FY26-002-QC Testing - Cost Quotation
Attachment B: RFQ FHI 360-FY26-002-QC Testing Acknowledgment Form
Appendices 1-4 - attached to end of RFQ
Please refer to the Instructions to Offerors section beginning on page 5 for detailed
instructions regarding the proposal format and submission requirements.
This request for quotations (RFQ) was issued by FHI 360 for the QTI (7200AA24C00095).
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Contents
Contents .................................................................................................................................. 2
ACRONYMS .............................................................................................................................. 4
FHI 360 ...................................................................................................................................... 5
PROGRAM BACKGROUND ...................................................................................................... 5
Description of the RFQ ........................................................................................................... 5
Scope of Work ............................................................................................................................ 6
Quote Specification ................................................................................................................... 6
Target Countries ........................................................................................................................ 7
INSTRUCTIONS TO OFFERORS ................................................................................................ 8
Quotation Format and Submission Procedure ....................................................................... 8
Intent to Participate/Not Participate ................................................................................... 8
Technical Quotation .................................................................................................................. 8
Cost Proposal Requirements .................................................................................................. 11
TERMS AND REQUIREMENTS ................................................................................................ 12
Acceptance ............................................................................................................................... 12
Terms ........................................................................................................................................ 12
Validity ................................................................................................................................... 12
Award Type ........................................................................................................................... 12
Work Products, Reports, and Deliverables ........................................................................ 12
Invoicing ............................................................................................................................... 12
Purchasing Restrictions ....................................................................................................... 13
Sample Subcontract Terms and Conditions ...................................................................... 13
Requirements ........................................................................................................................... 13
International Certifications ................................................................................................. 13
Quality Agreement ............................................................................................................... 13
Upon award, execution of a quality agreement will be used to ensure that
responsibilities and quality-related requirements are clearly defined. ......................... 13
Technical Specifications ....................................................................................................... 13
Source and Nationality Requirements ............................................................................... 13
AWARD CRITERIA ................................................................................................................... 14
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APPENDIX 1: SAMPLE TERMS AND CONDITIONS ............................................................... 15
General Terms and Conditions .............................................................................................. 15
Special Terms and Conditions ................................................................................................ 15
Appendix 2: Supplemental Terms and Conditions of the Purchase Order ........................ 16
Appendix 3: Invoicing Instructions ........................................................................................ 18
Order/Invoicing Process ..................................................................................................... 18
Appendix 4: Invoice Template ................................................................................................. 19
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ACRONYMS
ARV Antiretroviral drug
BP British Pharmacopeia
HPLC High-performance liquid chromatography
ISO International Organization for Standardization
OOS Out of specification
QA Quality assurance
QC Quality control
QTI Qualifying, Testing, Issuing Project
RFQ Request for quotation
SOP Standard operating procedure
UNICEF United Nations Children's Fund
USP U.S. Pharmacopeia
WHO World Health Organization
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FHI 360
FHI 360 is a nonprofit organization that mobilizes research, resources and relationships so
that people everywhere can access the opportunities they need to lead full, health y lives.
Our staff of more than 2,200 experts work in over 50 countries around the world.
PROGRAM BACKGROUND
QTI is a five-year contract (7200AA24C00095), with a five-year option period, implemented
by FHI 360. The program is led by FHI 360's Product Quality and Compliance department.
The QTI period of performance began in October 2024.
QTI implements a comprehensive quality assurance (QA) program to ensure the quality of
health commodities procured by various procurement service agents on behalf of the U.S.
Department of State's Bureau of Global Health Security and Diplomacy global health
supply chain. Per the QTI contract, the term QA is defined as the sum of all activities and
processes required to ensure that health commodities are of acceptable quality for clients
and patients.
The scope of commodities supported by the project includes but is not limited to the
following:
1. Finished pharmaceutical products
a. Antiretroviral drugs (ARVs)
b. Essential medicines
2. Nutrition products
3. Laboratory equipment, reagents, and consumables
4. Medical supplies and equipment
5. Rapid diagnostic tests
a. HIV (diagnosis, self-test kits)
b. Non-HIV
6. Other health commodities as requested
The program is also flexible to adapt to new product categories as needed.
Description of the RFQ
FHI 360 requests responsive quotations to provide laboratory testing services for the
following health commodities:
1. Finished pharmaceutical products
a. ARVs
b. Essential medicines
2. Nutrition products
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The following health commodities are not included in this RFQ but may need to be tested
in the future:
3. Laboratory equipment, reagents, and consumables
4. Medical supplies and equipment
5. Rapid diagnostic tests
a. HIV (diagnosis, self-test kits)
b. Non-HIV
6. Other health commodities as requested
Quotations must be provided in accordance with the instructions to offerors.
Scope of Work
Primary services to be provided: FHI 360 seeks services for testing finished
pharmaceutical products in the categories listed above in accordance with available
monographs (U.S. Pharmacopeia [USP], British Pharmacopeia [BP], International
Pharmacopeia [Ph. Int.]) when available or manufacturer methods if public monographs
are not available. FHI 360 also seeks services for testing nutrition products according to
the United Nations Children's Fund (UNICEF) specifications listed on Tab 5 of Attachment
A: FHI 360-FY26-002-QC Testing - Cost Quotation Excel sheet.
Samples will be shipped to the testing laboratory by FHI 360's assigned sampling agent.
FHI 360 or its appointed sampling agent will communicate with the vendor to ensure
samples are sent to the correct address and request any required documentation for
samples to enter the country when sampled internationally in a timely manner. Receiving
laboratories may be asked to assist with customs clearance for the samples entering their
country. The testing laboratory will report test results to FHI 360 and test reports will
include all test results, the test method used, and a statement about whether the results
comply with the relevant specifications or not. If a noncompliant test result is acquired,
the testing laboratory will also send a laboratory investigation report FHI 360.
Secondary services to be provided: For products that do not have a public monograph,
FHI 360 may request a transfer of the manufacturer's test method. Quotations for the
method transfer and subsequent testing of the product will be requested as needed.
Quote Specification
Quotations must include costs for all staff time, fringe, reporting, (chemical) consumables,
reference standards, etc. for testing each product quoted. Internationally recognized
methods (USP, BP, Ph. Int., UNICEF) are preferred.
Using reference standards for multiple lots tested at the same time is often more efficient.
Thus, the cost sheet allows organizations to provide quotations for testing one lot at a time
or multiple lots simultaneously.
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The cost sheet also allows organizations to quote additional costs if stage 2 or stage 3
testing for dissolution or content uniformity is required when results of stage 1 do not
comply with the specifications. FHI 360 must be informed if stage 2 or 3 testing is required
and the laboratory may not proceed without prior approval from FHI 360.
The organization may quote a one-time cost for specific nonconsumable supplies or
equipment (such as high-performance liquid chromatography [HPLC] columns) that must
be purchased before the first test and that can be reused for the next set of lots. Prior
approval to procure these items must be requested and received from FHI 360 before
purchase.
Testing laboratories will be responsible for destroying any samples that are left after
testing is complete. Destruction costs may not be billed separately.
In some cases, FHI 360 may require the laboratory to store the samples for a longer period
and will inform the laboratory prior to testing if this is needed.
In rare cases, FHI 360 may ask a third party to send the remaining samples to another
location. FHI 360 will inform the laboratory if this needs to happen.
Organizations bidding for two or more testing laboratories must submit separate
quotations for each laboratory and label as such on your proposal documentation.
Target Countries
Commodities purchased through the U.S. Department of State may come from an
extensive range of countries throughout North and South America, Europe, Africa, and
Asia. The exact locations are variable. Due to this complexity, FHI 360 will employ one or
more sampling agents to collect and send the test samples to the laboratory for testing.
FHI 360 will inform both the sampling agent and the testing laboratory the laboratory
address for shipping and ensure import process is conducted in a judicious manner. The
costs of shipping samples to the respective laboratories will be billed directly to FHI 360
through its DHL or other shipping account and are to be excluded from the cost quotation
sheet (Attachment A: FHI 360-FY26-002-QC Testing - Cost Quotation).
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INSTRUCTIONS TO OFFERORS
Quotation Format and Submission Procedure
Technical and cost quotations must be submitted as separate files. Both files may be
transmitted in the same email; however, each file must be named and clearly labeled to
identify the Offeror and quotation type (i.e., FHI 360-TECHNICAL, FHI 360-COST).
The subject line of the submission email must read: Quotation FHI 360-FY26-002-QC
Testing for QTI - Name of Offeror.
Offerors are not required to provide quotations for all testing services detailed in the cost
quotation template; however, offerors are encouraged to quote as many testing services
as possible to demonstrate their capacity. Offerors should only quote the testing services
for which the organization has current accreditation or World Health Organization (WHO)
prequalification.
The quotation, as well as all correspondence and documents relating to the quotation,
must be in English.
Intent to Participate/Not Participate
Please advise FHI 360 when you receive the RFQ and of your intent to submit or not to
submit a quotation by using the Attachment B: RFQ FHI 360-FY26-002-QC Testing
Acknowledgment Form and email it per the instructions in the cover of this RFQ
document by Friday, May 29, 2026, 5pm EDT. Bidders choosing not to participate must
immediately erase any electronic versions of this RFQ.
This RFQ in no way obligates FHI 360 to make an award, nor does it commit FHI 360 to pay
any costs incurred by the offeror in the preparation and submission of a proposal or
amendments to a proposal.
Quotations must be organized as shown below.
Technical Quotation
Obtaining consistent information from all bidders is essential if the evaluation criteria
established by FHI 360 are to be consistently and systematically applied in the assessment
of all responses. Bidders are therefore required to format their submissions in accordance
with the requirements outlined in this section of the document. Failure to follow these
requirements may result in the rejection of the response.
Technical quotations must be provided in Microsoft Word or PDF format and must include
the 12 sections listed below (in order). Each section must be numbered to match the
corresponding requirements. Technical quotations deviating from the specified format
may be disqualified, and unsolicited brochures and marketing materials will not be
reviewed. FHI 360 reserves the right to waive any administrative requirement.
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Section Technical Quotation Requirement
Brief (one page or less) introduction to the offeror's organization and its areas of
1
expertise
Evidence of International Organization for Standardization (ISO) 17025 accreditation,
2 WHO prequalification, or other relevant international credentials. Include all essential
information such as the scope of accreditation and expiration date(s).
Total number of staff dedicated to quality control (QC) testing, management, and filing
3
documentation
Description of major QC testing equipment and instrumentation (e.g., HPLC, dissolution,
4 apparatus, gas chromatography, high-performance thin-layer chromatography)
(including type, manufacturer, quantity)
Using a tabular format similar to the one below, provide historical QC testing data for the
offeror's organization, including:
Number of batches/lots of all products tested over the past three years, itemized
by product type (essential medicines, ARVs, etc.), active ingredient, strength, and
form (injection, tablets, capsules, etc.), as applicable
Each formulation type with laboratory testing method
Detailed information on testing the QC laboratory can conduct (assay, content
uniformity, dissolution, etc.)
Historical turnaround time for testing upon receipt of the samples
Product Active Test Number Historical Turnaround
5
Category Ingredient(s) Method of Lots Time
ARVs
Essential
medicines
Nutrition
products
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Section Technical Quotation Requirement
Use the following table to indicate the number of method transfers conducted over the
past five years (if applicable)
Product
Manufacturer Product
Category
ARVs
6
Essential
medicines
Antimalarial
products
Expected turnaround time for testing upon receipt of samples
7
Complete this information in the attachment titled "Attachment A: FHI 360-FY26-002-QC
Testing - Cost Quotation" in each of the commodity categories that are being quoted.
Indicate the number of laboratory investigations conducted over the past five years (if
8.
applicable)
Copies of standard operating procedures (SOPs) for:
Investigations and management of out of specification (OOS) results
9
Waste disposal procedures (high-temperature incineration is preferred)
SOPs for internationally accepted methods (Ph. Int. BP, USP) are not required.
Detailed past performance references (maximum of three) for major QC laboratory
10 testing contracts with details of the client, donor, end user/program, and contact
information including name, phone number, and email for each reference
Summary of procedures required for samples to clear customs to be received by your
laboratory. Indicate the level of experience of staff within your facility in interacting and
managing communication with all appropriate parties (e.g., courier, government agency)
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for customs clearance. Please provide any information available that indicates the typical
timeframe required to proceed through the clearance process after a sample has
shipped to your facility.
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