Sebastiaan Colenbie is Senior CMC Writer at Ardena Ghent. He has been supporting pharmaceutical development programs at Ardena for more than 10 years, with extensive expertise in CMC regulatory documentation and global regulatory submissions.
At Ardena, Sebastiaan specializes in the preparation of Module 2 (Quality Overall Summary) and Module 3 documentation for small molecules, including oligonucleotides and peptides, across therapeutic areas such as immunology, neurology, and oncology. He supports pharmaceutical clients throughout clinical development, preparing documentation for Phase 1 through Phase 3 studies, including INDs and IMPDs, for submissions across the United States, Europe, China, Japan, and South Korea. He also contributes to NDA and MAA submissions, as well as briefing books and responses to health authority questions, supporting effective regulatory interactions throughout the product lifecycle.
Sebastiaan obtained his Master’s degree in Biomedical Sciences from Ghent University. He combines extensive regulatory knowledge with a strong understanding of pharmaceutical development to support efficient and compliant progression toward key regulatory milestones.
