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Additional Services

Drug Design & Discovery

  • Early pharmacology with ADMET/PK prediction and QSPR
  • Structure and dynamics simulation
  • Virtual screening and docking
  • Molecule optimization and de novo design
  • Biopolymer and antibody design

AI -PBPK (physiologically based pharmacokinetics)

  • Quantitative systems pharmacology
  • Inhalation modeling and simulation
  • Virtual bioequivalence
  • Disease model
  • FIH dose justification and DDI risk assessment

Central Imaging

  • Bioequivalence studies
  • Phase I-III clinical trials
  • Investigator-initiated trials
  • Post-market studies

Regulatory Consulting

Experience with FDA, EMA, NMPA, and PMDA submissions.
1. Regulatory Strategy & Submissions
  • Strategy & due diligence
  • Registration, declaration & communication
  • Regulatory science & consulting
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2. Compliance & Safety
  • Labeling & advertising compliance
  • Post-listing life cycle maintenance
  • Drug alerts & safety compliance
3. Quality & Oversights
  • Quality systems & inspection support
  • Data governance & regulatory technology
  • Legal intelligence & training