Screening& Drug Evaluation
In Vivo Efficacy
PK Study
Toxicology
CTP
IND
6 months
8 months
Normal Process
4 months
6 months
Probio Record
  • Oncology in vivo model
  • ADME/PK
  • TK/ADA
  • RO
  • Single dose Toxicity
  • Repeated dose Toxicity
  • Bioanalysis

IND filling Package

  • M2.4/M2.6/M4 Package
  • Briefing book/RCP
  • Pre-IND meeting slides
  • CTD Package
  • IND submission

Service Features

  • Meeting the requirement for GLP and Non-GLP
  • Meeting the requirement for IND filling from different agencies, like FDA, NMPA and EMA, etc.
  • High one-time IND approval rate
  • One-stop solution with CMC team

Service Package

Service package
1、Single dose toxicology study
2、Dose-response-finding study (DRF)
3、Repeated dose toxicology study
4、Topical toxicity study
5、Safety pharmacology study
6、Tissue cross reactivity
7、Immunotoxicity