home > 전문가 컨설팅> 온라인 컨설팅서비스> 컨설팅 신청
프린트
전체 253건, 현재 페이지 10/26
GPKOL
기술마케팅 임상
- Work with pharmaceutical and Biotech companies in discussing their registration plans in Aisa, Japan, and EU - Discuss various partnership models to enable access to Aisa and Japan. - Generation of clinical development plans for registration strategy in Asia, China, Japan and the Rest of the world.
임상 인허가
러시아
- Drug Safety : Establishing and updating drug safety profile in clinical trials and post-marketing such as case identification, validation, medical coding, ICSR submission, RMP and PSUR, etc. - Medical Review : Providing high quality creative solutions for all phases of trial such as line-listing review, participation in DSMB, IEC/IRB meeting, etc. - Regulatory Affairs : Having applied knowledge and deep understanding of local (Roszdravnadzor in Russia, CFDA in China) and global regulatory requirements. - Audits : Conducting along with regulatory authorities participate in assessment of existing drug safety systems - Safety Database : E2B, EudroVigilance compliant, and specific Russian regulatory requirements.
인허가
스위스
- Regulatory affairs: Identifying regulatory strategy for pharma, biotech and medical devices companies - Management consulting: Advising organizations with cross-functional topics - Public Affairs: Advising companies on impact of new legislation on their organizations
스페인
- EU Regulatory Strategy, European registration through the Centralized and the Mutual Recognition/Decentralized procedures - EMA: Orphan Drug Designations, Scientific Advice, Briefing Meetings - European Member States: scientific advices and other consultations
인허가 GMP
브라질
- Regulatory affairs: Register of products in ANVISA, including the obtaining of necessary license and certificates - GMP: Prepare the company for Sanitary Inspection to obtain the Brazilian GMP (CBPF), and other required certificates
기술마케팅
대한민국
- INN/USAN(Global Regulation/Requirement): Availability Check, Development, Review, Submission, Consultation(유럽 및 미국 시장 진출 관련 성분명 허가 심사 자문) - Global Clinical Name&Logo(Pre-Marketing): Development Consultation(신약의 Global L/O, 환자모집, Publication 전략) - Global Brand Name&Logo: FDA, EMA, Health Canada, MHLW(Japan) brand name development and document preparation/consultation
인허가 임상 R & D기획
- Regulatory affairs: Appropriate rules governing medicinal products for human use in Russia, EAEU, and EU - Clinical Trial: Scientific aspects of clinical development, medical writing - R&D 기획: Development of generic and biosimilar medicinal products; new chemical entities/biologics
사우디아라비아
- Registriation in KSA(GCC)
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
- 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
