A key regulatory focus in 2025 is the control of critical quality attributes (CQAs) such as sequence fidelity, purity, and the presence of process-related impurities, including truncated or modified oligonucleotides. Both agencies require comprehensive documentation of synthesis protocols, validation of purification steps, and detailed characterization of the final product. The increasing use of solid-phase synthesis and automated platforms by leading manufacturers such as Lonza, Thermo Fisher Scientific, and Agilent Technologies has enabled higher batch-to-batch consistency, which is critical for regulatory approval.