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프린트
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GPKOL
임상
칠레
에콰도르
임상실험(Pi, Si, CRC)
R & D기획
- R&D Planning - Clinical Trial - GMP, GCP and Regulatory Affairs - Project management
- R&D Planning - Clinical Trial - GMP - Regulatory Affairs (RA)
기술마케팅 인허가 임상
태국
- (Technical Marketing)Export in commercial/ go to market strategies including; market entry. market access, distributor selection and management, sales and marketing management(new product launch, sales performance improvement) in SE Asia and Australian markets. - (Regulatory Affairs)Working knowledge of regulatory framework across SE Asia markets with strong connections within the pharmaceutical industry to manage the regulatory processes. - (Clinical Trials)Working knowledge of clinical trial processes, and access to industry leading experts in clinic trial management in Australia.
기술마케팅 GMP 인허가
미국
Global Pharma business development Comprehensive CMC data collection for FDA filings - CMO & CRO collaboration - Technology transfers - Process validation - Process development and optimization - DOE, QbD, cGMP compliance - Crystallization and isolation for scale-up
중국
- Drug R&D :CNS drug R&D, Co-development two new drugs with pharmaceutical companies, both of them are in Phase II; a new drug is in IND labeling - Regulatory affairs consulting: Provide consult to multiple pharmaceutical companies in term of technology and regulatory affairs - Scientific border member or counselor: Counselor for Shanghai Pharamresource, a company of pharmaceuticals, Border members for a few biopharmaceutical companies - Strategy planning and project managing: Lead the first pediatric drug research center in china, including establish and strategy planning for the center. - Expert consulting for CFDA: As a core member for pediatric drug research and development to provide expert opinion for pediatric drug R&D to CFDA in both technology and regulation
인허가
Biopharmaceutical Law, 인허가
기술마케팅
네덜란드
Cancer Biotech Business development, licensing and product launch projects
