私たちはCMC規制を知っています

Anke Moret is Director CMC Regulatory at Ardena, based in Ghent, Belgium. She brings more than two decades of experience in regulatory affairs, with expertise spanning CMC regulatory strategy, operational management, and regulatory project leadership. Anke first joined Ardena, then known as HEA, in 2001 as Regulatory Affairs Assistant. After leaving the organisation in 2005, she returned in 2009 as Regulatory Affairs Officer and progressed through several key roles, including Senior Regulatory Affairs Officer and Regulatory Project Manager. Since 2021, she has co-led the CMC Regulatory Business Unit together with Julie De Smet, with primary responsibility for operational management and delivery excellence within the unit. Anke holds a Master’s degree obtained in 2000 and has built extensive expertise in regulatory operations and project management throughout her career in the pharmaceutical industry. In her current role, she works in close partnership with Julie to ensure efficient execution of regulatory projects and to drive continuous improvement across the team.

Julie De Smet is Director CMC Regulatory at Ardena, based in Ghent, Belgium. She brings extensive expertise in CMC writing, dossier development, and regulatory strategy, supporting pharmaceutical development programmes from early phase through commercial. Julie joined Ardena, then known as Pharmavize, in 2012 as Regulatory Affairs Officer and advanced through several leadership positions, including Regulatory Affairs Project Manager, Subject Matter Expert in CMC writing, and Associate Director of Dossier Development. Since 2021, she has co-led the CMC Regulatory Business Unit together with Anke Moret, with a strong focus on scientific content, dossier quality, and regulatory strategy. Julie obtained her Master’s degree in Pharmaceutical Sciences from Ghent University in 2006 and completed her PhD in 2012, specialising in analytical method development to support pharmacokinetic studies. In her current role, she collaborates closely with Anke to ensure high-quality regulatory deliverables and to strengthen the integration of scientific expertise and regulatory requirements across projects.

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.

Frederick Duynslaeger is Senior CMC Writer at Ardena. Trained as an industrial pharmacist, he combines expertise in drug product manufacturing and formulation development with strong technical regulatory writing capabilities. At Ardena, Frederick specializes in translating complex pharmaceutical development data into clear and high-quality regulatory documentation. Using a dossier-centric approach aligned with global regulatory guidelines, he supports the authoring and review of Module 3 dossiers and related documentation across formulation development, technology transfer, and commercial submission activities. He also contributes to scientific integration across multidisciplinary development teams and supports strategic CMC activities and program management for pharmaceutical development programs. Frederick brings a combination of pharmaceutical development knowledge and regulatory expertise, supporting efficient and compliant progression of drug development programs toward regulatory milestones.

Joost Steverlynck is Senior CMC Writer at Ardena Ghent. He supports pharmaceutical development and lifecycle management programs through the preparation of regulatory and technical documentation for both emerging biotech companies and established pharmaceutical organizations. Joost brings more than five years of experience in the preparation of API-related documentation, including mutagenicity reports, synthesis criticality analyses, and nitrosamine risk assessments. His expertise focuses on supporting regulatory compliance and the development of high-quality CMC documentation across pharmaceutical development programs. At Ardena, he works closely with clients and multidisciplinary teams to support regulatory and technical documentation activities throughout the product lifecycle. Joost obtained his Master of Science degree in Chemistry from KU Leuven in 2012 and earned his PhD with a specialization in the synthesis of conjugated polymers. He subsequently completed a postdoctoral fellowship at KAUST, where his research focused on organic electrosynthesis for pharmaceutical applications.

Karen De Vreese, PhD, is Principal CMC Manager at Ardena. She brings nearly 30 years of experience across the pharmaceutical and life sciences industry, with extensive expertise in regulatory affairs and CMC documentation. Throughout her career, Karen has supported global pharmaceutical companies in the preparation, submission, and life cycle management of regulatory dossiers across multiple international markets, including Europe, the United States, Canada, Japan, China, and Russia. Her expertise includes the development of Module 2 (Quality Overall Summary) and Module 3 documentation for both small molecules and biologicals, as well as post-approval variations, responses to regulatory questions, and clinical trial documentation, including IMPDs and INDs. At Ardena, she works closely with clients and project teams to support high-quality regulatory submissions and ongoing dossier maintenance throughout the product life cycle. She also assesses the regulatory impact of change controls to support compliant implementation of development and manufacturing changes. Karen obtained her PhD in Medical Sciences from the University of Leuven. She began her career in virology research before transitioning into clinical development and regulatory affairs roles, combining scientific expertise with broad regulatory knowledge across development and commercial programs.

Kelly Van Looveren is Senior CMC Writer at Ardena Ghent. She supports pharmaceutical development programs through regulatory advice, scientific writing, and the preparation of CMC documentation for a broad range of development projects. After joining Ardena as a CMC Writer, Kelly progressed to the role of Senior CMC Writer, building extensive experience across regulatory documentation and scientific reporting activities. She has worked on projects for major pharmaceutical companies and combines her expertise in CMC documentation with a strong background in biotechnology and large molecule development. At Ardena, she works closely with clients and multidisciplinary teams to support regulatory compliance and successful development outcomes. Kelly graduated in Biochemistry and Biotechnology and obtained her PhD in Biomedical Biotechnology before joining Ardena.

Lieselotte Veryser is Senior CMC Writer at Ardena Ghent. She holds a PhD in Pharmaceutical Sciences and has been part of the CMC Regulatory team since 2016. Throughout her career at Ardena, Lieselotte has developed extensive expertise in supporting drug product programs from early development through market readiness. She focuses on the authoring and review of CMC documentation using a dossier-centric approach aligned with regulatory requirements in GMP-regulated environments. Her expertise includes pharmaceutical development, technology transfer, and regulatory documentation supporting high-quality drug product development programs. Lieselotte combines scientific expertise with strong regulatory knowledge to support robust and compliant pharmaceutical development activities.

Linde De Grande is Senior CMC Writer at Ardena. She brings 8 years of experience supporting pharmaceutical and biotech companies across drug product development and regulatory documentation within GMP-regulated environments. At Ardena, Linde focuses on developing clear and high-quality CMC documentation and supporting cross-functional teams across tech transfer, process validation, and lifecycle management activities. She is recognized for her structured approach and her ability to translate complex scientific and technical data into compliant regulatory documentation. Linde obtained her Master’s degree in Biomedical Sciences and earned her PhD in Pharmaceutical Sciences from Ghent University.

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.

Tessa Vermeire is Senior CMC Writer at Ardena Ghent. She brings more than six years of experience in CMC writing, supporting pharmaceutical development programs with a strong focus on regulatory documentation. Since joining Ardena, Tessa has contributed to the preparation of a broad range of regulatory documents, with particular expertise in Investigational Medicinal Product Dossiers (IMPDs) and Marketing Authorization Applications (MAAs). She is recognized for her structured approach, attention to detail, and ability to translate complex scientific data into clear and compliant regulatory documentation. At Ardena, she works closely with cross-functional teams to support the successful advancement of pharmaceutical development programs. Tessa obtained her Master’s degree in Biomedical Sciences in 2013 and earned her PhD in Health Sciences in 2019. She has developed her pharmaceutical and regulatory expertise through hands-on experience across CMC documentation and regulatory support activities.