«Grindeks» ensures research and development of active pharmaceutical ingredients in compliance with cGMP (current Good Manufacturing Practice) standards and suggests solutions meeting the specific client demands.
- LRP certified and API and intermediary products synthesis
- Specific technologies: lyophilization, electrodialysis, Grignard reaction, catalytic hydrogenation and etc.
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Complete analytical support - HPLC (including UV, MS, LSD, refractometrical detection), NMR, DSC, PXRD, IR, UV, CHN analysis, Atom absorption, etc. including validation of methods in GMP or GLP certified laboratories.
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Development and optimization
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Contract production in accordance with the LRP standards including methods validation and equipment washing validation
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Stability studies under ICH guidelines
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Development of active substance master files (ASMF) in CTD
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Solution of more complicated matters in liaison with the scientists from the Institute of Organic Synthesis, University of Latvia and Riga Technical University