If you have a potential new innovative drug product or combination product candidate that you would like to evaluate moving forward, QSI associates and it's US and Ex US based partners can assist your organization with feasibility thru late stage development work and author FDA submission ready documents.​​​ At QSI Associates, we focus on data-driven decisions throughout the entire development process.

​​

We start with the API and excipient characterization and preliminary formulation data, such at solubility, compatibility and stability. After the required data is collected and the formulation begins to take shape, we begin to focus on the drug delivery system, which allows our scientific experts to recommend the selection of the appropriate API and primary container closure system to be used for preclinical and clinical pharmaceutical development work. QSI associates also has a network of relationships with API, Excipient and Primary container closure suppliers that will assist in providing your organization with FDA acceptable raw material and primary container systems.

​​​​​

With significant biopharmaceutical experience, we factor in and anticipate clinical considerations as well as the in vitro performance of pharmaceutical formulations. Early laboratory prototyping is performed on bench-scale equipment, which mirrors both small-scale and mid-to-large-scale GMP manufacturing, to de-risk process scale-up and development should the product achieve its early clinical endpoints.​​​​ 

​​​​

Utilizing US based or Ex US labs we can provide turnkey solutions for the following studies:

Solubility

API/Excipient Compatibility

Filter Adsorption

pH adjustment and buffer capacity

Photostability

Componentry dimensional analysis

IVRT method development 

Product Physochemical Stability

Container Closure Integritiy CCI

Freeze/Thaw

Proposed API, Excipient and Componentry Specifications

Extractables/Leachables

Labeling

Packaging

​​​

​​

​​