Solubility Testing System

Background
The U.S. Food and Drug Administration (FDA), specifically the Center for Drug Evaluation and Research (CDER) and the Office of Pharmaceutical Quality (OPQ), is seeking a Solubility Testing System to enhance its capacity for solubility testing.

This initiative aims to reduce the need for in vivo bioequivalence studies by creating a solubility database that supports the development of a decision-making framework for identifying similar formulations of BCS Class III drug products. The FDA has identified gaps in solubility data from New Drug Applications (NDAs) and aims to address these through improved automated testing capabilities.

Work Details
The contract involves the procurement of one Solubility Testing System that meets the following minimum technical requirements:
- Newly manufactured, latest model, not used or refurbished.
- Sample containers must maintain a temperature of 37°C.
- Ability to stir samples at adjustable speeds during incubation, even for thick samples.
- Capability to operate multiple sample containers simultaneously.
- Apparatus must withdraw samples at different time points and can filter or centrifuge samples before sampling.
- Optional features include performing dilutions, monitoring pH, and direct connection with HPLC analysis.
- Warranty covering parts and labor for at least one year.
- Delivery, installation, and on-site training included in the price, which must cover all costs associated with system crating, shipping, and delivery.
- On-site performance testing must verify proper system operation.

Place of Performance
U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

Bidder Requirements
Bidders must comply with Section 508 accessibility standards as outlined by HHS. They are required to submit an Accessibility Conformance Report (ACR) based on the Voluntary Product Accessibility Template (VPAT). Additionally, bidders must provide information regarding the country of origin for the product/service to comply with the Buy American Act.