cGMP Regulations
One solution, seamless transition from Pre-clinical to Clinical to GMP Compliance
Qualio simplifies every stage of your product development with out-of-the-box FDA, ICH, ISO, and global GxP frameworks.
21 CFR Part 210/211
ICH E6 (R3)
Good Clinical Practice
ICH Q7
GMP Guide for Active Pharmaceutical Ingredients
ICH Q8
Pharmaceutical Development
ICH Q9
Quality Risk Management
ICH Q10
Pharmaceutical Quality System
ICH Q11
Development and Manufacturing of Drug Substances
ISO 9001:2015
Quality Management Systems
From Phase I to Approval and Beyond
Set your QMS up right from day 1
21 CFR 210/211 & ISO 9001 frameworks to accelerate your QMS build.
Easily ramp up for clinical trials
ICH E6 framework simplifies your gap analysis & audit-readiness.
Simple GMP transition
Scale up your maturity without the hassle. ICH Q7, ICH Q8, ICH Q9, ICH Q10 & ICH Q11 compliance in one system.
