Building A Path To Approval With Effective Regulatory Support

By Mira Han, Lead Specialist in Regulatory Affairs, Samsung Biologics

Adopting a right-the-first-time approach throughout development, manufacturing, and regulatory compliance is critical to minimizing risk, optimizing efficiency, and ensuring the successful approval of novel biopharmaceuticals. Each stage of the biologics lifecycle — from cell line development to commercial production — presents opportunities for delays, deviations, or compliance challenges that can impact timelines and costs. By prioritizing scientific rigor, process robustness, and proactive regulatory strategy from the outset, companies can significantly improve development outcomes and accelerate time to market.

Samsung Biologics delivers on these priorities with a comprehensive and flexible service model designed to streamline every phase of biologics development and manufacturing. Through its integrated regulatory support, global quality systems, and commitment to a right-the-first-time philosophy, Samsung Biologics helps clients navigate complex regulatory pathways and bring both traditional and next-generation biologics to market with speed, confidence, and efficiency.