Ensure ICH-compliance of your drug substance or drug product
To ensure product quality and patient safety, we perform physical, chemical, and microbiological testing for you in our contract laboratory.
Our certified laboratory offers a plethora of the analytical tests required for starting materials, bulk, and finished products. We are experienced in testing a wide range of compounds and formats and perform tests according to Ph. Eur. or USP methods. We are also able to design and validate in-house methods according to customer requirements if no standard method is available. In this way, we guarantee timely production, product release and distribution of safe products.
- Release and EU-import testing
- Analytical method development
- Microbiological testing
- Stability testing
- Testing capabilities
Release and EU-import testing
One of the most critical aspects of the GMP-based quality system is the final batch release of the drug product before it can be used in a clinical trial or released to the market.
To ensure the product has the required quality, the product and the documentation listed in the product specification file (PSF) must be reviewed by an independent Qualified Person (QP).
We can also facilitate the smooth import into Europe of your products manufactured elsewhere, by ensuring they comply with all required regulations and documentation.
Analytical method development
Our team of laboratory experts can call upon their experience in a broad range of analytical methods to develop a tailored method for accurately determining the physical and chemical properties of your drug substance or drug product. We can monitor your product’s critical quality attributes throughout the entire development process.
Microbiological
testing
Microbiological testing of pharmaceutical substances in a GMP-certified laboratory, both during manufacturing and of the finished product, is essential to ensure compliance. We provide advice and support in a multitude of tests to determine the microbial and endotoxin count of your drug substances and drug products.
Stability testing
Testing capabilities
We perform a broad range of tests for drug substances and drug products, including, but not limited to:
- 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
- Particle size measurements
- Pharmacopeial physical techniques
-
Tablet testing
- Dissolution
- Friability
- Hardness, disintegration
-
Residual moisture
- Karl Fischer
- Loss on drying
- Inspection of visual particulate matter
- Container closure integrity
