Other companies and Organizations

IND / NDA preparation and submission

  • Pre-IND regulatory(e.g. FDA) commucation
  • Original IND package preparation and submission
  • First in human ("FIH") study and medical safety monitoring
  • Key opinion leaders (KOLs) interactions and study design recommedations
  • NDA preparation and submission supports:
  • Integration safety summary (ISS) or summary of clinical safety (SCA)
  • Safety issues or concerns data preparation strategy and solution
  • Overall safety profile assessment and risk management planning
  • Labling development support
  • Post-marketing safety moniotoring planning

Real world studies and experience safety data review support

1. Real world studies

  • Safety data collection strategy
  • Data cleaning standardization, and quality control
  • Data processing and application design

2. Real world experience

Provide professional supports for:

  • Medication OTCs, nutrients, food supplements, medical devices
  • Patent population and risks assessment
  • Safety data monitoring and risk mitigation

Product complaint medication errors monitoring and management

1. Product complaint

  • Safety review plan
  • Medical assessment of potential impact
  • Post-marketing safety data retrieval and summary

2. Medication errors monitoring

  • AE data review and database search strategy
  • Issue driven data summary and presentation
  • Regular team review and risk medication
  • Summary and impact assessment for periodic safety update report

Online remote
PV monitoring and chronic disease risks management

1. Common drug safety risks monitoring

  • Drug-drug interaction
  • Drug-food interaction
  • Drug-disease interaction
  • Drug-use noncompliance​
  • Overdose
  • Drug abuse

2. Other safety risks