Without the necessary in-house capabilities, drug release testing can be costly, not only in terms of finance, but in time and expertise. You may have questions about when to begin testing, which global standards, and what documentation, will be required. Factor in retesting, equipment investment, or needing to test multiple samples, and the delays quickly add up.

Eurofins Medical Device Services network of laboratories is shaped to overcome these barriers. With scalable capacity, multi-shift operations, and a deep bench of technical expertise, we deliver the clarity, compliance, and control you need – on time and to the highest global regulatory standards.

Understanding the rate and extent of drug release is critical to predict in vivo performance and ensure regulatory compliance. 

Whether you’re developing clinical trial materials or releasing commercial batches, Eurofins Medical Device Services scientists are equipped to assess your drug substance, drug product, or in-process materials against rigorous specifications. We provide tailored analysis across identity, potency, impurity, safety, and physical property analysis under strict GMP compliance, with documentation developed to streamline regulatory submissions and internal workflows.

Comprehensive, Connected Service
Our services are designed to mitigate formulation and manufacturing risk, inform decision-making, and ensure consistent product quality with:

• In vitro testing to assess drug release profiles
• Method development and validation in accordance with regulatory guidelines
• Support for establishing in vitro–in vivo correlations (IVIVC)
• Routine quality control testing to ensure batch-to-batch consistency

Dosage forms and product types

• Implantables (including cardiovascular and ocular)
• Patches
• Suppositories
• Insulin pump
• Infusion sets

To match the complexity of today’s modalities, we offer testing of even the most sophisticated molecules at a single site, reducing hand-offs, turnaround time, and risk. Our laboratories perform both chemical and microbiological testing, alongside pyrogen, antibiotic potency, toxicity, and bioassay analysis where required.

Cutting-Edge Instrumentation

• LC/MS, LC/MS/MS
• HPLC/UPLC
• GC/GC-Headspace
• IC
• ICP-MS/OES
• GPC
• GC/MS, GC/MS/MS
• KF
• SEC
• TOC
• Dissolution Baths: Apparatus 1,2,3 & 5-Distek/Agilent-(formerly Varian)/Hanson/SOTAX
• Particle Size Testers (Malvern)

Every testing plan we design is calibrated to your timelines, production demands, and dosage form requirements. We offer the flexibility to manage both large-volume release programmes and smaller-scale needs with equal efficiency.

With global reach and local precision, Eurofins Medical Device Services network of laboratories is here to simplify your drug release journey, helping you to move forward faster, with confidence.