Pharma Compliance in Japan/AU/KR
Publicada el 2026-07-31
Descripción de la oferta
I hold an issued patent for a novel pharmaceutical product and I am now preparing to bring it to market in Japan, Australia, and South Korea. My immediate need is clear, practical guidance on product-specific regulatory compliance—everything that must be satisfied before we can legally sell in each jurisdiction. The engagement will cover: • A comparative roadmap for PMDA (Japan), TGA (Australia), and MFDS (South Korea) requirements—from dossier structure and GMP evidence to labeling, language, and post-market duties. • Estimated timelines, fees, and sequencing so I can plan clinical or bridging studies, national submissions, and launch milestones without costly rework. • Identification of any country-specific variations in pharmacovigilance, stability data, or packaging that could affect the core formulation. Acceptance criteria 1. A written compliance plan (one consolidated document, English) that I can hand directly to my regulatory affairs team. 2. A live walkthrough call to clarify assumptions and next steps. If you have recent hands-on experience shepherding small-molecule or biologic products through any of these agencies, I would value that insight. Please outline relevant approvals you have supported and your method for keeping guidance current with changing regulations.
Skills
Fuente original: freelancer