Bram Ach is CMC Writer at Ardena Ghent. He supports pharmaceutical companies in addressing increasingly complex regulatory requirements through the development of high-quality CMC documentation and scientific regulatory assessments.
Bram recently joined Ardena and already brings experience in the preparation of API-related documentation, including mutagenicity reports, synthesis criticality analyses, and nitrosamine risk assessments. His expertise spans both small molecules and biologics, with a focus on supporting regulatory compliance and risk-based decision-making. At Ardena, he works closely with cross-functional teams to translate complex scientific and regulatory topics into clear, practical, and compliant documentation that supports efficient development pathways and successful regulatory outcomes.
Bram obtained his Master’s degree in Chemistry from Ghent University. He combines strong technical expertise with a pragmatic, risk-based approach to support regulatory readiness throughout the development lifecycle.
