– Feasibility Evaluation
– For product filing in China, Hong Kong, Taiwan, South Korea & USA
– Document preparation (Document translation and organization)
– Sample Import
– Submission for IND/CTA and NDA/ANDA (Complete CFDA tracking)
Fountain Medical Development is experienced in registration and regulatory affairs in China and East Asia (including mainland China, Hong Kong, Taiwan, and South Korea). We provide regulatory strategy consulting services as well as registration dossier preparation and submission for IND/CTA, NDA and ANDA. Our dedicated regulatory team has years of experience and a solid track record in registration services for chemical compounds, biological products and medical devices.
In addition, we have a thorough understanding of the changing regulatory environment in China and have established a solid working relationship with regulatory authorities and government labs. The Fountain RA team has successfully achieved filings and approvals for 60 IND/NDAs in China.