QC Method Development

Quality Control & Analytical Sciences

1. From Analytical Procedure Development to Routine QC – Fully Integrated

Product-specific, purpose-driven analytical procedure development
Robust procedures for complex, sensitive, and unstable substances
Seamless transfer to routine QC

2. Science-Based, Application-Focused & Regulatory-Compliant

Science- and risk-based development and lifecycle management aligned with ICH Q14
Scientific depth combined with robust implementation in routine QC
Validation in accordance with ICH Q2

3. Infrastructure & Expertise

End-to-end analytical services from a single source
Broad range of in-house analytical technologies
In-house expertise complemented by specialized partner laboratories
Active EDQM PRP Working Party membership, contributing to Ph. Eur. monograph elaboration and revision
Scientific excellence, regulatory compliance, and efficiency

4. Our Laboratories & Core Technologies

Biology

Bacterial Endotoxin Testing
Microbial Enumeration
Microbial Identification
Sterility Testing
Viable Environmental Monitoring

Chromatography

Gas Chromatography (GC)
Ion Chromatography (HPIC)
High-Performance Liquid Chromatography (HPLC/UHPLC)

Chemistry & Spectroscopy

Elemental Analyses (CHNS, ICP)
Polarimetry
Spectroscopy (FTIR, NMR)
Thermal Analysis (DSC/TGA)
Titrations (Karl Fischer, potentiometric)
Total Organic Carbon (TOC)

Our R&D Expertise

Standards and Pre-clinical R&D

We optimize your lead compound into diagnostic or therapeutic (radio)pharmaceuticals by synthesizing and testing new molecules...

Radiopharmaceutical Development

You have developed a tracer – we take care of the rest.

Our Expertise in CDMO / CMO Services

At ABX, we continuously advance the development of new radiopharmaceutical solutions – from the initial idea to clinical application. We combine scientific excellence with practical feasibility, turning innovative approaches into market-ready solutions.