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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 117건, 현재 페이지 10/12

  • Soo Kyung Suh
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      임상
      인허가

    • 컨설팅 대상 지역

      미국

    • 컨설팅내용

  • Young Moon
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      R & D기획

    • 컨설팅 대상 지역

      미국

    • 컨설팅내용

  • Mihyun Nam
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      R & D기획

    • 컨설팅 대상 지역

      미국

    • 컨설팅내용

  • Sunjin Hwang
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      R & D기획
      임상

    • 컨설팅 대상 지역

      미국

    • 컨설팅내용

  • Hiroshi Nagabukuro
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      R & D기획
      기술마케팅

    • 컨설팅 대상 지역

    • 컨설팅내용

  • Hanlim Moon
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      R & D기획
      임상

    • 컨설팅 대상 지역

      미국

    • 컨설팅내용

  • 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

  • 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

  • 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

  • Ng Yin Mei
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      인허가
      기술마케팅

    • 컨설팅 대상 지역

      싱가포르

    • 컨설팅내용

      1. Regulatory, Quality and Project management ; Medical Device, IVD, Combination Drug-device, pharmaceutical, health supplement, cosmetic. Health software
      -R&D planning (DHF Design control), CMC/Quality advisory (DMF), Risk
      -Clinical trial (Performance/Clinical evaluation plan/report, Post market surveillance plan/report), Clinical trial protocol, application, funding and clinical trial sites with Singapore Hospitals.
      -Quality management system (ISO13485, MDSAP, GMP Brazil/Japan, US QSR, GMP compliance set-up, validation and warning letters solution team)
      -Regulatory Affairs (Regulatory Strategy for CE/US/Asia/Country of origin) for product approval of medical device, drug, cosmetic, AI, Software standalone or in device.

      2. Technical marketing ; Medical Device, IVD, Combination drug-device, drug
      -To provide training and consulting on overseas expansion strategy and marketing channel development in such case of Korean companies’ market expansion into emerging countries
      -To establish partner network for each market and region, especially on technology collaboration with Singapore researcher and investor

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