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Genotoxic Impurity Services
8 services found
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
Genotoxic Impurities Test: The control of genotoxic impurities is a complex and delicate project throughout the whole life cycle of drug development, and an important part of it is the assessment of genotoxic impurities. The study of genotoxic impurities involves ...
by:Affygility Solutions based inBroomfield, COLORADO (USA)
Have a pharmaceutical product that needs a formal genotoxic and carcinogenic impurity assessment to meet the requirements of ICH M7? The expert toxicologists at Affygility Solutions can assist your ...
Manufactured by:Regis Technologies Inc. based inMorton Grove, ILLINOIS (USA)
Regulatory agencies have acknowledged impurities, especially potential genotoxic impurities (PGIs), as a high priority in the drug development approval process. Since impurities found in pharmaceutical drug substances can potentially exhibit pharmacological activity, there are reporting, identification, and qualification ...
Manufactured by:SEQENS Group based inÉcully, FRANCE
Highly potent compounds, Steroids and Cytotoxics manufacturing capabilities. Read more. Oligonucleotides. Analytical Methods Development. Synthesis of Impurities and Standards. Potential Genotoxic Impurities Evaluation including High Sensitivity Analytical Methods. Solid State (Polymorphism screening / Salts / Co-Crystals). Read more. ...
Manufactured by:Regis Technologies Inc. based inMorton Grove, ILLINOIS (USA)
For over 50 years, Regis has been a premier custom small molecule manufacturer with excellent analytical support services. Regis’ analytical capabilities are now available to customers requiring stand alone pharmaceutical services. Our Analytical Method Development team (AMD) consists of highly skilled analytical chemists talented in developing and validating phase appropriate methods. Let ...
Manufactured by:SEQENS Group based inÉcully, FRANCE
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 ...
Manufactured by:Cambrex Corporation based inEast Rutherford, NEW JERSEY (USA)
The analytical testing methods used to monitor potency and purity for raw materials, drug substances and drug products are your primary view into the quality of your materials. Cambrex focuses on efficiently developing robust and high- quality analytical methods that deliver reliable results. We have a vast range of capabilities in instrumentation and detectors including high-throughput column ...
Manufactured by:SEQENS Group based inÉcully, FRANCE
Seqens is a world leader in pharmaceutical synthesis, capable of providing full CMC support to prepare for phase III clinical trials and drug registration globally in total compliance with the strictest regulatory, quality and EHS ...