Screening& Drug Evaluation
In Vivo Efficacy
PK Study
6 months
8 months
Normal Process
4 months
6 months
Probio Record
  • Oncology in vivo model
  • 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

Inquiry and order

Please download service quotation form and fill it before sending to us.