Over the years, Hybio has passed inspections from overseas and Chinese authorities and customers for an accumulated 150 times, covering its Shenzhen API site, Wuhan API site and Pingshan FDF site.


Meanwhile, Hybio has an excellent RA team with over 20 people, devoting to domestic and international registration and pharmacovigilance affairs; a group of expert consultants to assist our regulatory and application globally. Our team has rich experience on regulatory strategy, application and obtaining approval for pharmaceutical products, and on product lifecycle management.



Figures for your information:


1. Pakistan GMP inspection in 2010 (FDF);

2. US FDA GMP inspection in 2015;

3. EU AEMPS GMP inspection in 2015;

4. Brazil AVISA GMP inspection in 2017 (FDF);

5. US FDA GMP inspection in 2018;

6. South Korea MFDS GMP inspection in 2018;

7. 2018 EU EMA inspection;

8. Indonesia GMP inspection in 2018 (FDF);

9. Global and national customer GMP inspections for over 50 times;

10. China NMPA GMP inspections (national, provincial, and municipal) for over 90 times.

Coming inspections of TGA, FDA, EU in 2021 & 2022…