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Institutional communications, including Type 1, 2, 3 CDE advisory meetings and other meetings (including submitting communication requests, preparing communication documents and attending communication meetings to assist clients in communicating with regulation institutions).

Conduct a gap analysis of the archives of the CMC, non-clinical and clinical sections in accordance with relevant regulations and guidelines.

IND/CTA applications, NDA/BLA applications; Annual Report and Supplementary Application.

Monitor and follow up on review progress.



What you may be interested in: quality system, IP protection, corporate culture, partner style