With experience since 1993 in handling HPAPIs in accordance with cGMP, Cerbios is highly qualified as a Contract Development and Manufacturing Organisation (CDMO) for your HPAPIs from early stages, through clinical trials to commercial supply.
Cerbios is the ideal and reliable partner to support you at all stages of the development of your New Chemical Entity (NCE) or advanced intermediates.
The application of Design of Experiment (DoE) and Quality by Design (QbD) approaches, combined with a professional Project Management approach and team are paramount to the success of Drug Substance development.
Cerbios provides a comprehensive CMC service to support all aspects of the development, registration and commercial manufacturing of your molecule.
“Our client has continuous transparency on the development of their API throughout the entire programme and will have direct communication with each member of the project team”.
Cerbios provides full CMC support for your lead compound, from the development stages to commercial supply. On top of traditional chemical and analytical development activities, Cerbios can provide you with:
KSM identification and management
Supply chain management
Potency and toxicity assessment
Safety assessment
Strategic industrial and regulatory manufacturing consultancy
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To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
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The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
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