Formulation / CMC

OSOD provides support in early formulation of compounds, identifying endpoints and designing procedures needed to assess the physical and chemical characteristics of drug products to ensure their consistent quality during manufacturing later in the IND-enabling process. With our trusted partners who can provide the physical formulation and manufacturing support, OSOD can advise in submitting this information to regulatory authorities

Formulation development

 

  • Guidance on discovery formulation strategy needed to accomplish initial POC studies

  • Assist in moving lead candidates forward to formal formulation development through partner labs

 

Scale-up of drug product for toxicology studies

 

  • Provide strategic guidance to help inform test article needs for GLP tox studies through trusted partner labs

 

 

 

For more information about our team:

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