SGS INSTITUT FRESENIUS GmbH
About us
We are SGS – the world’s leading Testing, Inspection and Certification company
Address
Im Maisel 14
65232 Taunusstein
Germany
E-mail: de.pharmaqc@sgs.com
Phone: +49 4030 1010790
Internet: sgs-institut-fresenius.de/
Contact person:
Aline Weser
Sales Executive
E-mail: aline.weser@sgs.com
Phone: +49 174 1821259
Dirk Walter
Sales Executive
E-mail: dirk.walter@sgs.com
Phone: +49 173 6041582
Products & Services
Analytical Testing in drug development and quality control
SGS offers comprehensive testing services for the entire drug development life cycle - from early stage to release after GMP quality control.
Our superbly equipped, state-of-the-art laboratories offer comprehensive quality control according to the pharmacopoeia (e.g. EP, USP, BP or JP) or to your specifications. Thanks to our global network of laboratories, you benefit from local services and high-quality analyses.
We test:
Raw materials, excipients, active pharmaceutical ingredients, finished products.
Samples in the form of solids, semi-solids, liquids or gases
Packaging materials, containers
Stability Studies
Stability studies for pharmaceuticals
When you are ready to launch your medicines, you need to ensure that all applicable safety, quality, and regulatory requirements are met. With our support, you can ensure that your products are safe, effective, and meet the quality requirements of ICH, EMA, and FDA guidelines.
We have a wide range of drug stability monitoring studies. These include:
Long-term drug stability studies
Accelerated stability studies,
Lifetime assessment studies,
studies during use,
short-term temperature fluctuation studies, and
Forced degradation assessments in accordance with ICH Q5C and ICH Q1B.
Our specialized modern laboratories provide stability studies tailored to your specific project.
Extractables & Leachables testing
Extractables & Leachables testing
SGS offers:
Complete E&L support from study design to toxicological assessment.
Advanced analytical capabilities for unknown compound identification.
Expertise in pharmaceutical packaging, medical devices, and single-use systems.
Regulatory support aligned with EMA, FDA, USP, and ISO requirements.
Customized risk-based approaches and consultancy services.
Special Services
Special Services
Nitrosamines
PFAS
Particle identification and particle distribution
Cleanness of surfaces
Material failures and damage analysis
Environmental Monitoring
Gas Analysis