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.
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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