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CMC registration support

Hiray Pharma has a dedicated pharmaceutical affairs service team to provide domestic and international customers with CMC services and product management at different stages of clinical trial application (IND/CTA) and its clinical trial (P1, P2, P3), new drug application (NDA/MAA), generic drug application (ANDA), including product changes, annual reports and re-registration services.

Provide API full life cycle service management from R&D to production and marketing, communicate well with customers from the early stage of R&D, conduct forward-looking analysis of technical differences and pharmaceutical differences, timely and good interaction in the R&D process, and provide relevant CMC data of CTD data module 2 and module 3 and other forms of documents required by customers to meet the needs of different registration areas.



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