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GPKOL 온라인 자문 신청서 양식 다운로드(신청자 회사 소속확인, 회사직인)

다운로드 GPKOL 신청서 표지 워드파일 다운로드 GPKOL 신청서 내용 워드파일 다운로드

GPKOL 자문위원 리스트

전체 115건, 현재 페이지 9/12

  • Talal Ahmad Aburjai
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      GMP

    • 컨설팅 대상 지역

      요르단

    • 컨설팅내용

      - QA and QC of Drugs : Responsible for designing and consultations of many pharmaceutical and nutraceutical industries
      - RA : Consultant for JFDA for regulatory affairs
      - Pharmaceutical industries Audit : Accredited inspector for JFDA
      - Pharmaceutical industries : Formulas development and Method of Analysis development

  • Núbia Regina de Oliveira
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      인허가
      GMP
      인허가
      GMP
      인허가
      GMP

    • 컨설팅 대상 지역

      브라질

    • 컨설팅내용

      - Regulatory Quality Compliance.
      - Regulatory Affairs including product approvals and establishment of the companies (sanitary operational license and authorization).
      - Post-marketing surveillance (mandatory and voluntary notifications | treatement of adverse events claims)
      - Regulatory strategy.
      - Good Manufacturing Practices certification (planning, prepare, audits).
      - Regulatory support on import process.
      - Change management with uation of regulatory impact.
      - Risk management.
      - Due diligence for acquisitions.

  • Soo Bang
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      기술마케팅
      임상
      R & D기획
      PM

    • 컨설팅 대상 지역

      미국

    • 컨설팅내용

      Strategic Partnerships / Business Development / Alliances & Integration
      Relationship Management / Clinical Operations / Healthcare Systems

  • Richard Stokvis
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      기술마케팅
      임상
      R & D기획

    • 컨설팅 대상 지역

      스위스

    • 컨설팅내용

      - 유럽지역 사업개발 컨설팅

  • Thomas Rupp
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      GMP

    • 컨설팅 대상 지역

      독일

    • 컨설팅내용

      - GMP
      - DNA/RNA Manufacturing, CMC
      - Therapeutic Development
      - Traning & Workshop experience

  • Yi-chung Lu
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      인허가
      PM

    • 컨설팅 대상 지역

      대만

    • 컨설팅내용

      Regulatory Affairs

  • Vinodkumar Indure
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      R & D기획
      임상
      PM
      인허가
      기술마케팅
      GMP

    • 컨설팅 대상 지역

      인도

    • 컨설팅내용

      ~ Well-differentiated formulation Development
      ~ Pharmaceutical New Product Development strategies
      ~ Patent Non-Infringing formulation and process development
      ~ Conceptualization/Ideation, Feasibility Studies
      ~ Competitive Intelligence and Investment De-Risking Strategies
      ~ CMC /CTD/ eCTD Development and review
      ~ IMPD/IND/NCE opportunities - 505(b)(1) products
      ~ NDA opportunities - 505 (b)(2) products
      ~ ANDA - 505 (j), First-To-File Products & Paragraph IV product opportunities
      ~ Novel Drug Delivery Systems - NDDS Products
      ~ Proprietary Formulations and Platform Technologies Development
      ~ Unmet Medical Needs Assessment
      ~ Real-World-Examples and Commercial Assessment
      ~ Product Life-Cycle-Management (LCM) Strategies
      ~ Health Economics and Outcomes Research (HEOR) Analysis
      ~ Product Portfolio building
      ~ Rare/Orphan Drug Development opportunities
      ~ Revival of "Dead Clinical Assets” by applying Multi-Disciplinary Technological Approaches
      ~ Managing Teams of Multidisciplinary Scientists
      ~ Product Development Budgeting, Timelines and Project Management
      ~ Scale-Up, Validations and Technology Transfer
      ~ KOL Profiling & Engagement as per product requirements
      ~ Clinical Supplies, CRO, and CDMO Engagement

  • Werner Krause
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      임상

    • 컨설팅 대상 지역

      독일

    • 컨설팅내용

      임상개발

  • 김태원 (Taewon Kim)
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      임상
      R & D기획

    • 컨설팅 대상 지역

      미국

    • 컨설팅내용

      독성학
      신약개발에 관련한 R&D기획, 전임상, 독성학 실험과 Regulatory submission

  • 이정재(JungJae Lee)
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      R & D기획

    • 컨설팅 대상 지역

      미국

    • 컨설팅내용

      1. R&D Planning : All projects include R&D Planning, Clinical Trial, GMP, RA, Technical & Marketing, and PM through collaborations with Pharmaceutical companies and Medical Centers: MTTI (www.mtarget.com, PA, USA), Precision Membranes (www.precisionmembranes.com, UT, USA), BostonSight (www.bostonsight.org, MA, USA), MEEI (www.masseyeandear.org, MA, USA) and Anschutz Medical Campus (www.cuanschutz.edu, CO, USA).
      2. Drug Delivery Systems (DDS) for Cancer Treatment.
      3. Molecular Imaging (MI) for Cancer Detection
      4. Therapeutic Contact Lens for Eye Diseases

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