ResolveMass Laboratories Inc. メール確認済み

ResolveMass is a US FDA-registered pharmaceutical laboratory in Canada offering end-to-end drug development and regulatory support, serving as a trusted North American CRO/CMO partner. Its services include peptide drug development (injectable and long-acting formulations, ANDA sameness evaluation), biosimilar development (comparability studies and regulatory submissions), generic drug development (method development, validation and stability testing), extractables and leachables testing (mass spectrometry-based E&L studies), nitrosamine testing (FDA- and EMA-compliant risk assessment), and bioanalytical services (GLP-compliant method development for small and large molecules).