Keystone Pharma Consulting provides consulting services to the pharmaceutical and chemical industry in the field of solid state research, crystallization and particle technology.
Keystone helps biotech companies bridge the gap between drug substance and drug product development to provide a better drug substance in support of drug product development through:
- increasing solid state knowledge and understanding of the drug substance (DS) and drug product (DP)
- defining optimal requirements for the Active Pharmaceutical Ingredient (API) associated with a targeted dosage form
- increasing understanding of process parameters influencing the properties of the API
- redesigning the final isolation step of the API to
- optimize physical and particle properties
- develop dosage forms with optimal and consistent drug product performance
- defining control requirements and developing adequate analytical methods
- providing technical guidance for regulatory and IP strategy
Whether you have polymorph issues or your API exhibits poor flow properties, whether you are struggling with a poorly soluble compound or need technical oversight for solid state analytical development or regulatory filing, Keystone Pharma Consulting can help you.
While focusing primarily on pharmaceutical applications, Keystone also provides guidance for complex materials science and crystallization projects in diverse fields including food science, agrochemicals, and specialty chemicals. Prior experience includes work on:
- Glycerides, e.g. for use in Melt Spray Congeal (MSC) process
- Cannabinoids
- Glycosides, e.g. rebaudiosides/steviosides
- Small molecule agrochemicals
- Specialty chemicals, e.g. thermal inks
Please browse to our Services page to learn how we can help!