Whether you're up against timelines, constrained by budget, or unsure about current regulatory expectations, there's no room for uncertainty when it comes to analytical method development and validation. The Eurofins MDS network of laboratories provides deep experience across a wide range of drug and device products to develop, optimise, validate, and transfer methods that are precise, phase-appropriate, and fully compliant.

We employ a method lifecycle management approach, tailoring our support to your development phase, from early characterisation to late-stage validation. Our laboratories are equipped with cutting-edge instrumentation and highly trained scientists who apply state-of-the-art techniques including:

• High-performance liquid chromatography (HPLC)
• Liquid chromatography-mass spectrometry (LC-MS)
• Gas chromatography-mass spectrometry (GC–MS)
• Gas chromatography with flame-ionization detection (GC-FID)
• Gas chromatography with Thermal Conductivity Detector (GC-TCD)
• Gel permeation chromatography/size-exclusion chromatography (GPC/SEC)
• Spectroscopy
• Inductively coupled plasma mass spectrometry (ICP-MS)
• Mass spectrometry (MS)
• Ultraviolet-visible (UV-Vis)
• Fourier-transform infrared spectroscopy (FTIR)
• Additional Techniques
• Total organic carbon (TOC)

Our method development process begins by clearly defining your analytical goals, including the critical quality attribute(s) to be measured, applicable reference standards, and the method’s intended use. Where possible, we accelerate progress by drawing on validated in-house methods. For novel drug substances or medical device materials, we develop robust new approaches aligned to your product’s lifecycle.

We validate each method against essential performance parameters: specificity, linearity, range, accuracy, precision, detection and quantitation limits, and robustness. We also conduct forced degradation studies to support stability-indicating methods. When methods need to be transferred in or out of a facility, our teams execute the process with speed and precision, ensuring continuity and data reproducibility across sites. Our network model allows for seamless transfers between Eurofins laboratories.

Every step is designed to meet and exceed global regulatory expectations, including:

• Code of Federal Regulations (CFR) 311.165c
• ICH GUIDELINE Q2 (R1), ICH 2005 
• FDA 2015 and FDA 2018
• USP <1225> USP <1226> and USP <1058> 
• ISO 10993-18 
•  ASTM F1635