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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

cGMP Regulations

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.

Replace lagging, manual compliance work with seamless collaboration that accelerates product delivery.