Vendor Questionnaire.pdf
PDF 71 KB Posted
- Solicitation number
- CDER-2026-131716
About this file
This is a Vendor Questionnaire for a Sources Sought Notice issued by the U.S. Food and Drug Administration (FDA), Office of Pharmaceutical Quality Research (OPQR), regarding retrofit services for a Glatt GCG-70 Inline Continuous Screw Blender-Mixer to enable signal exchange with third-party equipment.
The questionnaire requests company information including name, UEI Number, business size status, and socioeconomic category. The technical capability section requires vendors to provide detailed responses on six key areas: experience with retrofit or integration of pharmaceutical processing equipment; experience integrating equipment with distributed control systems such as SIMATIC PCS 7; experience performing equipment installation, commissioning, and qualification in laboratory or pharmaceutical environments; confirmation of ability to meet salient characteristics specified in Section 3 of the Sources Sought Notice; identification of the vendor's role as OEM, authorized service provider, or systems integrator; and up to three relevant past performance references with organization, project date, and brief description. The instructions emphasize that questionnaires must be completed fully and submitted as requested, with incomplete submissions potentially excluded from consideration. Vendors are explicitly prohibited from submitting capability statements, brochures, or supplemental marketing materials.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| revRequirements Document (3).pdf |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Vendor Questionnaire
Retrofit to Glatt GCG-70 Inline Continuous Screw Blender-Mixer for Signal Exchange to Third-Party Equipment
U.S. Food and Drug Administration (FDA) – Office of Pharmaceutical Quality Research
(OPQR)
Instructions:
Please complete this questionnaire fully and submit it as requested in the Sources Sought Notice. Do not submit capability statements, brochures, or other supplemental marketing materials. Incomplete questionnaires may not be considered.
1. Company Information
• Company Name: ___________________________________________
• UEI Number: ___________________________________________
• Business Size Status (Small/Large): _________________________
• Socioeconomic Category (Small Business, 8(a), HUBZone, SDVOSB, WOSB, etc.):
2. Technical Capability
1. Describe your experience performing retrofit or integration of pharmaceutical processing equipment or similar laboratory equipment:
2. Describe your experience integrating equipment with distributed control systems (DCS) such as SIMATIC PCS 7:
3. Describe your experience performing equipment installation, commissioning, and qualification in laboratory or pharmaceutical environments:
4. Confirm that your company can meet the salient characteristics described in Section 3 of the Sources Sought Notice (Yes/No and details):
5. Identify whether your company is the OEM, authorized service provider, or systems integrator for the equipment:
6. Provide up to 3 relevant past performance references (organization, project, date, brief description):
File details come from the government source that posted it. Updated .