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Leveraging the latest NMPA guidelines and employing strategies such as population pharmacokinetics and adaptive design to ensure scientifically sound clinical trial protocols and improve first-pass approval rates.
Maintaining annual cooperation frameworks with over 30 GCP centers, enabling rapid subject recruitment and ethics approval, providing efficient resource support for clinical trials.
Equipped with dedicated monitoring, data management, and biostatistics teams, covering bioequivalence studies, Phase I-III trials, PK/PD studies, and human food trials, ensuring high-quality project delivery.
Service cases span diverse types including generic drug combination bioequivalence studies, preclinical trials for novel anti-gout drugs, and health food human trials, demonstrating cross-therapeutic area delivery experience across various registration categories.