hybioCRO Services
Hybio offers a complete range of peptide CRO services, supporting the entire drug development process for your Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) projects. Our highly skilled and trained R&D team, state-of-the-art facilities, and proven track record ensure the highest standards of service.
Our CRO services encompass process development, preparation and characterization of in-house standards, impurity studies, isolation and identification of both known and unknown impurities, analytical method development and validation, stability studies, Drug Master File (DMF) preparation, and comprehensive regulatory support.
hybioCDMO Services
Hybio has established itself as a leading company in peptide drug research and manufacturing in China, thanks to our extensive experience in peptide R&D technology, manufacturing, and quality regulation. We offer a full portfolio of peptide products and services.
Our CDMO platform includes peptide API synthesis and purification process development, finished dosage form development, reference standard preparation and qualification, studies and analyses of impurities and product quality, a GMP system that meets EU and FDA standards, and international and Chinese regulatory and dossier support. We provide safe and efficient guidance for complex peptide drugs, from development through to commercial production.
For any inquiries, please feel free to contact us at sales@hybio.com.cn, or by calling +86-755-26588093.