Preclinical Peptide Stability: Design Considerations for EU IND Submissions
Understanding ICH S7A, Q1A(R2), and EMA Bioanalytical Method Validation requirements for peptide stability studies supporting EU regulatory packages.
26 March 20262 min read
Research Repository
Research Blog
Technical articles for EU pharmaceutical professionals on peptide CDMO sourcing, preclinical workflows, and regulatory compliance.
EMA Guidelines on Synthetic Peptide Drug Substance Characterisation: 2025 Update
A comprehensive review of EMA reflection papers and guideline updates affecting identity, purity, and impurity control for synthetic peptide APIs in EU regulatory submissions.
20 March 20262 min read
CDMO Selection Criteria for EU Peptide API Manufacturing: A Decision Framework
Key evaluation dimensions for selecting a European peptide CDMO: synthesis technology capabilities, quality systems maturity, regulatory track record, and commercial terms.
12 March 20262 min read
Sourcing GMP-Grade Peptides for Phase I Trials: A Practical Guide
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.
11 March 20262 min read
