QSI Associates
Solutions
for Your Specific Development Stage
Inception and Conceptualization
Even in the very first stages of your product conception, the value of outside and unbiased opinion is immeasurable. A significant amount of information can be garnered in as little as one hour, from new innovative ideas to development paths that should not be pursued. A relatively inconsequential investment can save significant time and money in the long term.
Formulation Development & Pre-Clinical
While preparing formulation development or pre-clinical animal studies, having a extra set of eyes to review experimental plans/designs, protocols, data analysis, anlytical blood plasma method development and reports can be invaulable. QSI can also provide this work as a service provider.
Phase I & II Clinical
Now that the product will be used by Human patients, it will need to be manufactured under cGMP conditions, even if it is on a very small scale. Also, analytical methods need to be validateable and specifications of raw materials and componentry need to be created. QSI Associates can assist with all of this and provide FDA submission ready documents.
Technical Transfer
So at this critical juncture, you need to select and contract with a Contract Manufacturing Organization CMO, but there are so many out there. QSI has vetted many CMOs in the US and has working relationships with many more. QSI can assist in the selection and contract negotiations with the CMO and provide technical project management services for the client during the progression of the project.
Commercialization & Post Market Approval
If the product is in the initial release stage or it is a mature life cycle product, QSI Associates can assist with customer complaints, Adverse Medical Events AEs and or failure investigations. QSI can also provide guidance/assistance with FDA interaction throughout these processes.