Laboratory
Ensure compliance of your drug substance or drug product
To ensure quality and safety, our laboratory offers physical, chemical, and microbiological testing for starting materials, bulk, and finished products. We follow Ph. Eur. and USP methods or develop and validated in-house methods to meet your specific requirements.
Overcoming Key Challenges in Pharmaceutical Manufacturing
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Final Batch Release
We guarantee GMP-compliant batch release for clinical and commercial drug products. An independent Qualified Person (QP) reviews product and documentation to ensure quality.
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Analytical Method Development
Our experienced laboratory team leverages a broad range of analytical techniques to design tailored methods for accurately determining the physical and chemical properties of your drug substance or drug product.
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EU Import
We facilitate smooth EU import of medicinal products by ensuring full regulatory and quality compliance, including batch testing and release by a Qualified Person (QP) in accordance with EU requirements.
Testing Capabilities
Our laboratory offers a broad spectrum of testing services for drug substances and finished products. Explore some of our capabilities below:
- HPLC (UV, DAD, IR and fluorescence detection)
- Droplet size distribution (DSD) and spray pattern analysis
- Cascade impactor
- UV and IR spectroscopy
- Identification testing and limit tests (Pharmacopeial physical techniques)
- Tablet testing (Dissolution, Friability, Hardness/disintegration)
- Residual moisture (Karl Fischer and Loss on drying)
- Inspection of visual particulate matter
- Container closure integrity
Stability testing
We provide ICH-compliant stability testing for drug substances and drug products in our state-of-the-art climate chambers. With approximately 100 m² of controlled space, we ensure precise temperature and humidity conditions to guarantee reliable results.
- In‑use stability studies
- Accelerated and long‑term stability studies
- Climatic zone II, IVa, and IVb stability programs
Unlock Your Laboratory Potential
Contact us today to explore how our laboratory services can elevate your projects to new heights.