Keystone Pharma Consulting, LLC

Keystone Pharma Consulting leverages expertise in physical chemistry, crystallization and particle technology, and experience of pharmaceutical development from pre-IND through commercial stage to help companies optimize physical and particle properties of the API and develop dosage forms with optimal and consistent drug product performance. Keystone consulting services primarily are targeted towards small biotech and large pharmaceutical companies, with the aim of bridging the gap between drug substance and drug product development. Services focus on technical, strategic, and regulatory guidance to clients in the field of materials science, crystallization, and particle engineering, primarily in support of drug substance and drug product development. Examples of activities include: • Data review and strategic guidance • Preparation of Request for Proposals • Selecting suitable CRO/CDMO and overseeing projects, e.g. o polymorph, salt, cocrystal, and amorphous dispersion screening o solid state and particle property characterization and method development o physicochemical testing of drug substance and drug products experimental design for crystallization process development o de-risking and troubleshooting of DS and DP processes o scientific review of project updates and reports • Defining API needs for DP development activities • Technical input on the use of PAT techniques • Preparation of summary reports or presentations • Regulatory guidance associated with solid forms and particle characteristics • Technical writing expertise relating to relevant sections of IND and NDA through submission • Strategic guidance for intellectual property protection • Scientific review of patents While focusing primarily on pharmaceutical applications, Keystone may also provide guidance for complex materials science and crystallization projects in diverse fields including food science, agrochemicals, and specialty chemicals.