ICH is the global body to harmonize requirements. For Generic drugs, ICH’s approach will be crucial to standardize all requirements.
Bioequivalence studies in Humans
This is prime requirement in world of generic medicines.
WHY Third Party Auditing-Monitoring in Clinical Research?
This is need of an hour. Third eye is always useful while working in the regulated environment.
Root Cause Analysis of the Data Integrity Issues
This is the challenge industry is facing currently.