|
Services / Analytical Method DevelopmentAnalytical research and development involves studies regarding pre-formulation, formulation, stability, and degradation. The purpose is to establish the identity, purity, physical properties, and potency of the active ingredient - this also includes bioavailability, solubility and stability.
Kamat Pharmatech provides clients with qualitative, quantitative, descriptive, and experimental data (GLP) regarding New Chemical Entities and Biologics leading up to clinical studies following FDA, ICH, and USP guidelines.
In the early development phase, Kamat Pharmatech aims to develop an analytical method that is well-understood, but not final. The validation is not necessary until phase I studies, although method validation may be requested by the client earlier. We attempt to build method robustness with good laboratory practices and good documentation practices. Relevant Instruments
|