Crystal Pharmatech has rich experience in the development of new drug products during the whole life cycle. Based on the concepts of Quality by Design (QbD) and Fit-for-Purpose (FFP), a suitable formulation development strategy will be adopted in view of the characteristics and technical requirements of different kinds of products at different stages. We aim to develop a robust formulation and process for your product, to rapidly advance to different stages of clinical research. Product changes will be minimized in the subsequent clinical and marketing process to achieve comprehensive and efficient development goals by scientific bridging study design.
As a professional pharma formulation company, we have top-notch equipment and instruments for formulation development and analysis, which can support the development of oral solid dosage forms at all stages from early clinical to commercialization. The first-time success of GMP production of clinical samples can be effectively guaranteed and thus saving the development cost and shortening the development cycle by taking the following strategies: compaction and mathematical simulation technologies, similar critical equipment between GMP and R&D, and the same personnel responsible for R&D and GMP production of clinical samples.
A well-designed formulation should have appropriate bioavailability, good physicochemical, biological and microbiological stability, and a robust manufacturing process.