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A well-known pharmaceutical company passed FDA Inspection successfully under our guidance!

2025/3/25      view:

Great news continues to arrive! Following the success of NCPC Aino, our company has once again assisted a renowned pharmaceutical company in Hubei Province to successfully pass the on-site inspection conducted by the U.S. Food and Drug Administration (FDA) from March 17th to 21st, 2025. After five days of intense and high-pressure testing, the company achieved an excellent result with zero 483 observations, adding another brilliant chapter to the internationalization process of pharmaceutical enterprises. Behind this glorious achievement lies our core driving force of customized regulatory services, which have crafted a "secret guide" tailored for the company to pass the inspection.

It is particularly noteworthy that we demonstrated our exceptional cross-project collaboration capabilities during these two consecutive weeks of inspections. Two elite teams were dispatched to different battlefields for the two projects that were almost simultaneously ongoing: the "Regulatory Shield" team, using regulations as a shield, escorted NCPC Aino to a successful conclusion; and the "Intelligent Breakthrough" team, using wisdom as a sword, overcame the inspection challenges faced by the Hubei-based company. Together with the closely connected regulatory think tank in the rear, they forged a powerful synergy and continued the glorious chapter of our customized regulatory services.

"Daily efforts never cease, and every contribution will eventually pay off." The success of this inspection is not only a powerful testament to the company's own strength but also a brilliant demonstration of the value of our customized regulatory services. Looking ahead, with multiple official inspections on the horizon, we will surely provide even greater enthusiasm, more professional attitudes, and more precise services to help more Chinese pharmaceutical companies sail overseas and jointly write a new chapter for the industry.