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전체 256건, 현재 페이지 11/26
GPKOL
인허가
사우디아라비아
- Registriation in KSA(GCC)
임상 인허가
미국
- Regulatory affairs/clinical research professional with extensive experience in regulatory affairs, clinical research and drug development at FDA, NIH, and industry, emphasizing drugs, biotechnology and medical device products. - Experience in the use of computers in document preparation and submission, IND/NDA submissions, adverse experience reporting, clinical regulatory compliance and strategic planning
임상
대한민국
- GCP Managment/START-up(Country&Site approach&selection)/Trial Operation Management - Global Project Start-up & Management/Technology & Process/Business Development - Quality Managment for Clinical part/Auditing & CAPA strategy - Resource & talent training in bio-industry (Productivity & efficiency management) - EP unit set up & business
기술마케팅
과테말라
- 과테말라 의약품 무역 등 중미 진출 관련 자문
GMP
- API CMC: API CMC (Active Pharmaceutical Ingredient: chemistry, manufacturing , and controls), including route selection, process optimization, scale-up, tech transfer for cGMP manufacturing - Solid polymorphism: Crystallization, polymorph screening and the control - Oligonucleotide: Detailed process chemistry support for raw material management of cGMP oligonucleotide manufacture, including supplier qualification, supplier audit, and developing raw material control strategy such as setting and justifying specifications.
임상 인허가 R & D기획
- Clinical trials, - R&D Planning, - Regulatory Affairs
R & D기획
- Antibody: Antibody discovery, Andtibody drug development - Cell line development: Cell line development for antibody production - Antibody optimization: Affinity maturation for lead optimization
- R&D Planning and strategy: All area of Early Discovery R&D planning and strategy including and not limited to hit discovery, hit to lead, Target ID, Target Validation - Company founding & management - Key Technology / Scientific discovery
- 국내기술 해외이전/Partnering - 국외기술 국내이전 - 시장요구 반영을 통한 NCE 개발, Drug Discovery 지원, Target area 선정 - 기술개발 로드맵 작성 지원
- Drug Discovery(R&D): Structure-based drug design in cancer, neurodegenerative diseases (Parkinson’s Disease), malaria and dengue