BOC Science’s formulation R & D team has accumulated many years of experience in drug discovery research, providing one-stop, systematic formulation services to meet the needs of customers at different stages of pharmaceutical development. We are familiar with a variety of ICH, FDA, and CFDA regulations and guidelines to provide you with comprehensive and reliable data.
Our formulation services include, but are not limited to, following:
Before conducting pharmaceutical drug product formulation activities, pre-formulation studies are initiated. In the pre-preparation stage, the physical and chemical properties of the active drug component (API) were determined. The knowledge gained from API helps to select appropriate salt or polymorphic forms and supports the design and development of initial dosage forms for preclinical and clinical use.
Based on the profound knowledge of properties of your drug candidates and inactive components, our scientists will guide you through decisions and provide advice to design the most appropriate formulations regarding the release characteristics or bioavailability. We are specialized in designing and development of various dosage forms, including tablets, capsules, creams, lotions, ointments, gels, non-sterile liquids and suspensions as well as sustained or extend formulations.
Our experts have an insightful perception for the importance of adhering to the highest standards of quality, development of robust analytical procedures and efficiently testing and controlling the raw materials, intermediates and final products.
The generic consistency evaluation is composed by quality conformance and efficiency consistency. Evaluation of pharmaceutical quality conformance is defined to determine whether your generic drug preparation and reference formulations are consistent with the key quality indexes such as the dissolution and related substances. Treatment efficacy consistency is evaluated by bioequivalence assay.
Why choose BOC Sciences?