- Do you have a risk of solid-state transition of the drug substance in your drug product?
- Do you need to prove to authorities the robustness of your manufacturing process and the stability of your product?
- Are you going to use less stable polymorph, cocrystal, salt or amorphous form in your formulation?
- Will the safety, efficacy, performance, or manufacturability of the drug product be affected by solid-state form transition?
- Do you need to evaluate the particle size of a drug substance in your product?
- Searching for help to identify foreign particles or color changes in your product?
- Need to measure the thickness of a coating of your tablets or capsule walls?
We will help you to develop the analytical methods and mitigate the risks.