API INTERMEDIATE SERVICES
API and intermediates process development services
API and intermediates manufacturing services
Registration Filing and Regulatory Services
Learn how Hiray Pharma shares their proprietary technology with you.
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.
What you may be interested in: quality system, IP protection, corporate culture, partner style