Description
The FDA is seeking a contractor to provide a flowsheet modeling and simulation software license, specifically gPROMS or equivalent, to support the agency's quality assessment of emerging pharmaceutical manufacturing technologies. The software should include model libraries for various pharmaceutical processes, such as blending, granulation, and tablet coating. The contractor will be required to provide maintenance and technical support, as well as training for FDA personnel. The contract will have a base year and four option years, with a total duration of five years. The FDA is looking for a contractor that can provide a comprehensive solution that meets the agency's technical requirements and is available at a competitive price.
Key features of the required software include:
* Flowsheet modeling environment for conventional pharmaceutical processes
* Intelligent line routing and clearly differentiated stream types
* Steady state and dynamic process models for all common process equipment
* Custom modeling capabilities to create user-defined models
* Dynamic flowsheet models that include elements of process control
* Parameter estimation from experimental data to support model validation
* Global sensitivity analysis to analyze the impact of inputs and model parameters on process outputs.
Attached files
Contact
Robert Waite(Contract Specialist)