Research Repository
Technical articles for EU pharmaceutical professionals on peptide CDMO sourcing, preclinical workflows, and regulatory compliance.
A comprehensive review of EMA reflection papers and guideline updates affecting identity, purity, and impurity control for synthetic peptide APIs in EU regulatory submissions.
Key evaluation dimensions for selecting a European peptide CDMO: synthesis technology capabilities, quality systems maturity, regulatory track record, and commercial terms.
A systematic framework for qualifying peptide CDMOs for first-in-human studies, covering vendor audit criteria, Certificate of Analysis requirements, and ICH Q7-aligned quality agreements.
