As per USFDA, peptides that are produced by synthetic or recombinant technology are regulated as drugs, and fall outside the scope of guidance written for traditional small molecule drugs as well as for biologics. Whereas as per European Pharmacopeia’s monograph Substances for Pharmaceutical Use contains reporting, identification, and qualification thresholds for impurities in synthetic peptides, but this is not globally followed and does not apply to genotoxic impurities. This makes Peptide manufacturing more challenging to determine appropriate impurity limits. In order to match these regulatory expectations, our team at GenPep is engaged to understand the thorough requirement of agency right from the drug development to minimize/avoid post submission queries. Team GenPep will provide all regulatory support from development till approval of drug product.