Commercial
TirzPharm has been manufacturing cGMP peptides for more than 15 years and has recently obtained a Recommendation for Approval for the commercial production of Exenatide to create commercial API following a thorough FDA audit. Our objective is to guide our clients from the research clinical trial phase all the way to market commercialization. Our Quality Team will provide the necessary documentation required for regulatory product submissions, such as a Drug Master File, upon request. Our value-added services encompass process development, scale-up production, analytical/process validation, stability studies, CMC, DMF, and FDA regulatory support. It is essential for us to collaborate closely with our clients. We have undergone audits by numerous clients and would be pleased to welcome any members of your staff to visit our facility for an audit or inspection.
Clinical
Our advanced cGMP facilities have been specifically designed for the production of GMP peptides. The GMP Manufacturing Group has successfully produced numerous clinical-grade peptides for toxicology studies, as well as Phase I, Phase II, and Phase III clinical trials across the globe. Our team possesses extensive knowledge in assisting clients throughout the clinical process to ensure that all necessary requirements are fulfilled, whether you need a single cGMP grade peptide or multiple cGMP grade peptides for peptide vaccine or clinical comparison studies.
Non-clinical
TirzPharm provides a comprehensive range of popular peptides for research and development purposes. These peptides are available in various prepackaged quantities and are ready for immediate use. Each peptide is accompanied by a complete quality control package, which includes HPLC analysis to verify purity and mass spectral analysis to confirm identity. We encourage you to explore our catalog to find any peptide by research area, sequence, or common peptide name. Should you be unable to locate the peptide you seek, please feel free to reach out to us for assistance and/or a quotation for non-clinical peptides.
Analytical
TirzPharm provides a comprehensive range of services in pharmaceutical, chemical, and peptide analysis. Our analytical laboratories comply with current GLP standards and are furnished with cutting-edge analytical instruments. Each service is managed by highly trained and skilled chemists who can deliver advanced testing within a swift timeframe. Additionally, our offerings encompass analytical/process method development and validation, stability studies, CMC, DMF, and complete regulatory support. We invite you to reach out to us to discuss your analytical needs. .