지디에프아이 브레인셀연구소

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Regulatory Affairs Services

국제법령과 글로벌 임상표준화를 충족하는 GDFI Braincell Laboratory

30년 이상의 규제기관의 다양한 경험과 전문성을 확보한 최고 기술 보유자와 글로벌 임상 경험 전문가에 의한 국내외(MFDS,FDA) 규제기관과 ICH 규정을 충족하는 Protocol Template를 사용, 적합성이 높은 IND/NDA Dossier를 제공해 드리며 국책과제 개발 및 관리업무를 수행합니다.

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고객사가 요구하는 R&D 기획, 비임상시험 및 신약개발과제 기술컨설팅의 핵심 요구 사항을 파악하여 기술적 대응력을 높이고 있습니다.

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국내외 임상시험에서 연구자 선정에서 임상 개시까지 계획된 일정에 따른 임상진입 Start Set Up 업무의 만족도를 높여드립니다.

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4-1. Regulatory Affairs (RA)

  • Strategic & Regulatory Affairs
  • Regulatory Strategy Consulting
  • Planning of pharmaceuticals development strategies
  • Non Clinical Research Consulting
  • Support for MFDS Consultations & liaison with regulatory authorities
  • Study Design Consulting
  • Strategic & Regulatory Affairs
  • Regulatory Strategy Consulting
  • Planning of pharmaceuticals development strategies
  • Non Clinical Research Consulting
  • Support for MFDS Consultations & liaison with regulatory authorities
  • Study Design Consulting
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4-2. Project Development (PD)

  • Regulatory Strategy Consulting (IND/NDA)
  • Pre-clinical Test Consulting
  • CMC Consulting
  • Clinical Study Strategy Consulting
  • Clinical Study Design Consulting
  • Pre-IND Meeting Consulting (FDA,MFDS)
  • Develop National Project Management
  • Regulatory Strategy Consulting (IND/NDA)
  • Pre-clinical Test Consulting
  • CMC Consulting
  • Clinical Study Strategy Consulting
  • Clinical Study Design Consulting
  • Pre-IND Meeting Consulting (FDA,MFDS)
  • Develop National Project Management
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4-3. Start Set Up Service (SSU)

  • Feasibility Study Investigator, Site Selection
  • PSSV(Pre-study site visit), Site Qualification visit
  • IRB Submission
  • IP Management
  • Investigator New Drug (IND)
  • GMP (Good Manufacturers Practice) & GSP (Good Supply Practice) Services
  • Preparation of New Drug Application (NDA) & Re-examination Application
  • Preparation of Clinical Trial Notification (CTN)
  • Feasibility Study Investigator, Site Selection
  • PSSV(Pre-study site visit), Site Qualification visit
  • IRB Submission
  • IP Management
  • Investigator New Drug (IND)
  • GMP (Good Manufacturers Practice) & GSP (Good Supply Practice) Services
  • Preparation of New Drug Application (NDA) & Re-examination Application
  • Preparation of Clinical Trial Notification (CTN)
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