QbDC Overview

Who are we?

QUALITYBYDESIGN CONSULTANCY (QbDC) was formed in 2008 to provide innovative companies with a service for implementing Quality by Design (QbD) and Process Analytical technology (PAT) into their operations. With over 10 years of proven global experience in the regulated industries, QbDC is well placed to help your organization meet many of its regulatory and training needs.

Expertise in:

-GxP including GAMP

-Analytical and Process Validation

-Process Analytical Technology (PAT)

-Quality by Design (QbD)

-Design of Experiments (DoE)

-Multivariate Statistical Process Control (MSPC)

-Formulation and Scale Up

-Training in multiple disciplines

What we do.

Whether you are an innovator, generics, complementary or contract manufacuturer, QbDC can offer training and consultancy services that are highly pragmatic in their approach and are results driven. The following products and services are offered by QbDC

-GxP Examiner: is a flexible training software package that allows you to incorporate both QbDC developed training modules, or your own in-house modules in a secure and validated environment.

-Process and Analytical Method Validation: Development of protocols and analysis of process or analytical data for developing regulatory submissions for solid, liquid and biopharmaceutical products and intermediates.

-Process Statistics: Services including Statistical Process Control (SPC), Multivariate Statistical Process Control (MSPC), Sampling Plans, Design of Experiments (DoE), Pragmatic Risk Analysis and Root Cause Analysis.

-QbD and PAT Services: World recognized expert in the development and implementation of Quality by Design and Process Analytical Technology projects in the pharmaceutical, biopharmaceutical and medical industries.