Ardena Ghent

Since 2019, Ariane has overseen Ardena’s drug product activities, spearheading successful integration and transformation at Ardena Pamplona and expanding the company’s capabilities to include sterile services.

Arnout Everaert is Head of Drug Product Europe at Ardena, where he leads the company’s drug product development and manufacturing strategy across its European operations.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Annelies Paridaens is Director of Project Management at Ardena Ghent. She brings extensive experience in clinical supply and a strong track record in managing complex pharmaceutical development programs. At Ardena, Annelies focuses on ensuring efficient project execution, aligning stakeholder expectations, and maintaining high quality standards across development activities. She is known for her structured approach, pragmatic leadership style, and clear communication, as well as her ability to navigate complex technical and regulatory challenges. She works closely with internal stakeholders and international clients, translating technical requirements into clear project strategies and fostering collaborative partnerships. Annelies is committed to supporting the efficient advancement of innovative therapies and contributing to Ardena’s mission of accelerating the path from molecule to medicine.

Daan Vanhaecke is Group Leader for Formulation Development and Production at Ardena. As an industrial pharmacist, he combines hands-on technical expertise with a structured and quality-driven approach across GMP manufacturing and pharmaceutical development environments. Prior to joining Ardena, Daan built experience across several pharmaceutical companies, contributing to equipment qualification for ATMP manufacturing and Quality Assurance oversight activities. At Ardena, he is responsible for the day-to-day management of GMP production projects and associate scientists, including troubleshooting technical and GMP compliance challenges to ensure projects are delivered on time, within budget, and in compliance with cGMP standards. Daan brings experience across both QA and manufacturing environments and works closely with internal stakeholders and clients to support the successful development and production of innovative therapies.

Wannes Deckers is Associate Director of Quality and serves as a Qualified Person (QP) at Ardena. He brings extensive experience in pharmaceutical quality assurance and investigational medicinal product manufacturing within GMP-regulated environments. Wannes began his career through a Trainee Qualified Person program at MSD, where he built a strong foundation in cGMP compliance. Throughout his career, he has held multiple quality and pharmaceutical leadership roles, including Industrial Pharmacist and QP at Air Liquide Medical, as well as Responsible Person (GDP) for VitalAire NL. Prior to joining Ardena, he worked as a Project Engineer and consultant at Pfizer, supporting Pre-Approval Inspections (PAI) for analytical operations across several biosimilar programs. At Ardena, he focuses on phase-appropriate GMP manufacturing and successfully led the implementation of the company’s aseptic manufacturing facility, including cleanroom and isolator qualifications and aseptic manufacturing processes. He currently combines QP responsibilities with broader quality leadership activities across pharmaceutical operations. Wannes obtained his Master in Drug Development and his degree in Industrial Pharmacy from Ghent University.

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.

Laure Descamps is Senior Formulation Scientist at Ardena, specializing in solid dosage development and process understanding. She supports formulation design, process optimisation, and early-phase drug product development for complex pharmaceutical programs. At Ardena, Laure applies her expertise to developing robust formulation strategies that support the efficient advancement of complex molecules toward clinical evaluation. Her work focuses on formulation development and process understanding across early-stage drug product development activities. Laure obtained her Master’s degree in Drug Development and Industrial Pharmacy and earned her PhD from Ghent University’s Laboratory of Pharmaceutical Process Analytical Technology. Her doctoral research focused on tabletting behaviour, material characterisation, and compression challenges in collaboration with industry partners.

Dr. Raja Yekkala is Business Development Director at Ardena. He brings more than 20 years of experience across pharmaceutical sciences, CMC development, analytical sciences, drug product development, clinical supply, and manufacturing support. At Ardena, Raja focuses on strategic business development for integrated pharmaceutical development and manufacturing programs in both human and veterinary applications. He supports clients throughout the full development journey, from early-stage activities through clinical phases, working closely with multidisciplinary teams across formulation development, analytical development, GMP manufacturing, regulatory affairs, project management, and clinical supply. His expertise includes comparator sourcing strategies, clinical trial supply planning, and the coordination of complex clinical supply programs supporting global development activities. Over the course of his career, he has contributed to bringing several dozen compounds into clinical development. Prior to transitioning into business development leadership roles, Raja held scientific and project management positions at Ardena and Pharmavize, where he managed complex CMC programs, clinical supply manufacturing activities, and cross-functional development projects. Earlier in his career, he worked as a research scientist at KU Leuven, contributing to pharmaceutical analysis, method development, and pharmacopoeial monographs adopted by the WHO. Raja is a pharmacist by training and obtained his PhD in Pharmaceutical Chemistry and Drug Analysis from KU Leuven, Belgium. He is author and co-author of multiple peer-reviewed scientific publications, contributor to internationally recognized pharmacopoeial monographs, and co-inventor of a patent related to pharmaceutical formulation technologies.

Sander Delahaye is Group Leader in Analytical Chemistry at Ardena Ghent. He brings extensive expertise in analytical method development, validation, and lifecycle management within GMP-regulated pharmaceutical environments, with a strong focus on chromatographic techniques and physicochemical analysis. Prior to joining Ardena, Sander worked at Ajinomoto OmniChem as Group Leader in Analytical Development, supporting the development and commercial manufacture of active pharmaceutical ingredients (APIs). During this time, he built extensive expertise in analytical method development and validation in accordance with ICH guidelines, with technical experience spanning GC, HPLC/UHPLC, and orthogonal analytical techniques, including Karl Fischer titrations. He also played a key role in GMP release testing, as well as the validation and troubleshooting of analytical methods for large-scale synthetic processes. After a decade focused on API analytical development, he transitioned to Ardena to broaden his expertise toward drug product development, supporting formulation development, release testing, and stability studies for clinical trial materials. Sander obtained his Master’s degree in Chemistry from Ghent University, followed by a PhD specializing in separation sciences. His doctoral research focused on the fundamental principles of supercritical fluid chromatography (SFC) and contributed to the understanding and optimization of this technique for complex analytical applications.

Seppe De Smet is Director of Analytical Development. He leads the definition and execution of analytical strategies supporting drug product development across the full product lifecycle at Ardena. He focuses on aligning scientific, regulatory, and client needs through phase-appropriate analytical approaches, control strategies, and lifecycle management. Throughout his career, Seppe has supported programs from preclinical development through clinical stages and commercialization, providing end-to-end analytical oversight tailored to each phase of development. He has worked across both CRO and biotech environments, combining project leadership with scientific expertise in small molecules and biologics. His experience includes method development, validation, GMP-compliant analytical operations, regulatory submissions, and CMC-related processes including manufacturing, quality control, and release testing. Seppe earned his PhD in Analytical Chemistry with a strong focus on chromatography. At Ardena, he supports clients through high-quality and pragmatic analytical solutions designed to accelerate development timelines while ensuring product quality and regulatory compliance.

Dr. Timothy Pas is Associate Director, Formulation Development and Production at Ardena. He leads a team supporting formulation development and GMP manufacturing activities for early clinical programs. Since joining Ardena, Timothy has progressed from Formulation Scientist to Group Leader and currently Associate Director. Throughout his career at Ardena, he has developed extensive expertise in oral and parenteral formulations, formulation development strategies, and GMP manufacturing operations supporting early-stage pharmaceutical development programs. Timothy obtained a Master’s degree in Drug Development and earned his PhD in Pharmaceutical Technology from KU Leuven, specializing in enabling technologies and galenic principles.

Vicky De Paepe is an HR Manager with experience across industrial and biotech environments. She brings extensive expertise in HR business partnering, organizational transformation, and people management within complex and evolving organizations. Vicky started her career in an all-round HR role within the automotive sector in Antwerp before joining Ablynx as HR Officer. Over the years, she progressed into senior HR roles and ultimately became HR Manager. Following the acquisition of Ablynx by Sanofi in 2018, she transitioned into the role of HR Business Partner for the Ghent R&D site, supporting the organization through significant transformation initiatives, including multiple reorganizations and a collective dismissal process in 2024. After this transformation period, she joined Ardena for a new professional challenge. Her experience combines operational HR expertise with a strong focus on organizational change, stakeholder support, and people-focused leadership within dynamic business environments.