SEQENS Group
Analytical Excellence Services
FromSEQENS Group
Seqens provides GMP testing on Active Pharmaceutical Ingredients (API) and excipients. We have an extensive team focused on the development and clinical phase appropriate validation of sensitive and specific analytical methods. Our analysts work closely with our chemists to develop In Process Control, isolated intermediate, and finish product release and stability indicating methods.
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Our in-deep technical expertise in analytical science combined with the most advanced analytical instrumentation ensures fast and reliable execution of analytical programs that range from routine tests to highly complex developments.
Our core expertise includes:
- Characterization of Active Pharmaceutical Ingredients and comparative testing
- Development and validation of analytical methods
- Impurities testing
- Genotoxic impurities studies
- Stability study according to ICH (International Harmonization Council)
- Drug Substances and Drug product GMP testing
- Pharmacopoeia (USP/NF, EP, JP, BP) raw material GMP testing
- Extractable & Leachable studies
- Investigative analysis
- Qualification of reference standards