API Section of IND
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Agno Pharma has the expertise and experience to be your reliable single-source IND format and content provider of the API section. Our comprehensive service starts with synthesizing your first GLP and GMP batch(es), characterizing your API and its related substances, establishing a reference standard and reference materials, developing and validating analytical testing methods, conducting stability studies and testing, releasing toxicology and clinical batches, and compiling the required CMC documentations. These services are conducted under ICH cGMP requirements to meet the regulatory expectations.
