What we do

E&L

• Extractables and Leachables study
• GOOD to know I
• GOOD to know II
• Seminar
  • WEBINAR
  • 2019
  • 2020
  • 2021
  • 2022
  • 2023
• E&L case study
  • FDA 사례연구
  • MFDS 사레연구
  • Medical Device 사례연구
• USP 1663
  • BRIFING
  • PURPOSE
  • KEY TERMS
  • SCOPE
  • BACKGROUND
  • GENERATING THE EXTRACT
  • EXTRACTING MEDIUM
  • EXTRACTION TIME & TEMP
  • CHARACTERIZING THE EXTRACT
  • SUMMARY
  • Example Extractables Profiles—Materials Chara
• USP 1664
  • PURPOSE
  • KEY TERMS
  • BACKGROUND
  • CONCEPTS
  • SAFETY THRESHOLDS
  • LEACHABLES STUDY DESIGN
  • LEACHABLES CHARACTERIZATION
  • SAMPLE PREPARATION
  • VALIDATION
  • LEACHABLES–EXTRACTABLES CORRELATION
  • SIMULATION STUDYS
  • INORANIC LEACHABLES
• USP 1664.1
  • INTRODUCTION
  • KEY TERMS
  • LEACHABLES ASSESSMENT
  • DOSAGE FORM TYPES
  • CONSIDERATIONS
• ICH Q3E
  • Concept
• PQRI
  • PQRI Guidance
  • PART III Best Practices for E&L Asseessment i
  • PART III-II Characterization
• 한국식약처고시
  • 제2022-80호(22년11월)
• 용기적합성평가(MFDS)
  • 가이드라인
• USP 665
  • USP665 BRIEFING
• Medical Device

Contract Service

• M4 : The Common Technical Document (CTD)
• Impurity
  • SERVICES
  • ICH Q3A
  • ICH Q3B
  • ICH Q3C
  • ICH Q3D
  • ICH M7
• Protein Characterization
  • SERVICE
  • ICH Q6B
  • mAb Service
• Particle
• Container Closure Integrity
• Cleanning Validation
• Nitrosamine
• PFAS
• Data integrity
• Other Service

SAINT-GOBAIN

• TUBING SELECTION GUIDE
• C-Flex® TPE
• Sani-Tech® STHT-65 and STHT-C
• Sani-Tech® Ultra-65 and Ultra-C
• Sani-Tech® Sani-Link®
• Sani-Tech® STHT®-WR
• PharMed® BPT
• SANIseal
• Single-Use Assemblies
• Bioprocess Bags
• Bio-Simplex®
• Final Fill Custom Assemblies

자료실

• 용기적합성
• Saint Gobain
• Texcell
• Becton Dickinson
• 공지사항
• Photo
  • SWISS
  • PARIS

About Us

• Vision
• Business Partner