Kymos Group offers GMP-certified importation, batch testing and batch release services. We have several QPs and are certified importers and manufacturers (MIA holders) for quality control and batch certification of human, veterinary and investigational medicinal products (IMPs).
We have the capability to perform GMP batch testing and batch release for sterile, non-sterile and biological medicinal products. Most of our batch testing clients are global manufacturers from countries without mutual recognition agreements (MRA) who wish to import their products within the European Economic Area (EEA). Here batch testing is mandatory prior to batch release. Our service pack also includes batch release for such manufacturers thus enabling them to entrust us with their products until market release.
Services
Our Solution for GMP Batch Testing & Batch Release
Services
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Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.
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Laboratory including cleanroom with airlock technology and HEPA filters for testing of sterile and non-sterile APIs and drug products.
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Complex characterization projects for innovative biologics and comparison of biosimilars.
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