Quality Assurance specialists in pharma and biotech
Quality Assurance
Welcome to the Arex Quality Assurance team. Our experienced specialists offer strategic advice and operational support in GMP, GLP and GDP.
Welcome to the Arex Quality Assurance team. Our experienced specialists offer strategic advice and operational support in GMP, GLP and GDP.
Nelly Fransén
Partner
Head of Development & QA
PhD in Pharmaceutical Sciences
Nelly specialises in formulation development, regulatory CMC and quality assurance. Her expertise includes formulation technologies and drug absorption from development to tech transfer, scale up and production support. Nelly supports our clients with expert advice on CMC documentation, regulatory strategies, product and process improvements, QA assignments within both GDP and GMP such as QMS set-up, acting responsible person, qualified person or performing audits. She is a Pharmacist with a Doctorate in Pharmaceutical Sciences from Uppsala University, and has previously worked as Director R&D and Responsible Person GDP in a smaller pharmaceutical company. Nelly is based in Lund, Sweden.
Alina Makedonska
MSc Industrial Biotechnology
Alina’s core experience is in regulatory affairs and CMC, and she has also worked in quality assurance, developing quality systems and preparing sites for GMP inspections. She has been responsible for the successful registration of 10 new marketing authorisations, and has project managed many technology transfer processes. Alina has an MSc in Biotechnology from Kyiv Polytechnic Institute and joined us after working as Head of RA and QA at Movi Health. She is based in Lund, Sweden.
Azadeh Khoshegir
BSc Biomedical Science
Azadeh specializes in regulatory CMC, with a strong background in global projects within big pharma. Her experience includes managing life-cycle submissions of variations, renewals, US Annual Reports, MAAs, and responses to health authority queries. She also has solid experience in quality supplier management. Azadeh most recently worked at AstraZeneca. She received her degree from Umeå University.
Callum Kitson-Parker
MChem Medicinal Chemistry
Callum is a medical device specialist with over 8 years of experience working within MedTech and pharma, specifically within quality, regulatory, and product development.
He is experienced in developing quality and regulatory strategy, establishing compliant QMSs and leading ISO certification processes, acting as both PRRC and Management Representative in his previous roles. He also manages outsourced medical device development and manufacturing projects, regulatory submissions, and product registrations. Callum is a graduate of the University of Leeds. Callum is based in Lund, Sweden.
Henrik Svederud
MSc Chemical Engineering
Henrik is a specialist within quality assurance in drug development (GMP, GCP, GDP). He has over 15 years of experience within a wide range of QA tasks, including as RP and QP working with release of raw materials, APIs, intermediates, IMPs and finished products, as well as with quality audits. Henrik’s latest position was as Senior QA Manager at Hansa Biopharma, and he received his education at Lund University. Henrik is based in Lund, Sweden.
Isak Simón
MSc Pharm
Isak works in regulatory affairs and quality assurance. His main focus is GDP, regulatory lifecycle management and compliance review. Isak joins Arex after a role at ApoEx, where he specialised in the distribution and provision of unlicensed medicines for early access, e.g. on a named patient basis or compassionate use. He has previously worked at the Swedish Medical Products Agency with parallel import and the National Medication List.
Juho Bah
Partner
PhD in Organic Chemistry
Juho is a senior professional in regulatory affairs. Working at the intersection of CMC, quality assurance and regulatory, he maintains a focus on global regulatory projects, technology transfers and life-cycle management. After obtaining a PhD in Organic Chemistry from KTH, he worked in companies of varied sizes and therapeutic profiles, taking on various regulatory responsibilities during pharmaceutical product development.
Katarina Alheim
Partner
Chief Quality Officer
PhD in Neurochemistry and Neurotoxicology
Katarina specialises in quality assurance and pharmacovigilance. She has specific experience in quality management systems, both for GDP and for pharmacovigilance work. Katarina has held the position of Responsible Person for many years and has experience from inspections by most of the Nordic Competent Authorities for medicine. She holds a PhD in Neurochemistry and Neurotoxicology from Stockholm University.
Maria Flärd
Licentiate, Analytical Chemistry
Maria is a senior specialist in in drug development with over 25 years of experience from quality assurance and regulatory affairs for biologics, specifically oncology and monoclonal antibodies. At Arex Maria will enhance our CMC and quality assurance side with skills in setting up drug development programs and quality systems, as well as managing regulatory submissions and preclinical/clinical studies. Her latest position was at Prevas, and her degree in Analytical Chemistry comes from Lund University. Maria is based in Lund, Sweden.
Martina Johannesson
PhD Medical Science
Martina specializes in drug development, with over 20 years of experience in cell therapy from early pre-clinical to clinical phase. She focuses on regulatory affairs, project management, and medical writing in drug development – all with an emphasis on ATMP (Advanced Therapy Medicinal Products). Her most recent role was Cell Therapy Program Manager at Idogen. She holds a PhD in human embryonic stem cell research and an MSc in Molecular Biology from Lund University. Martina is based in Lund, Sweden.
Michelle Co
Partner
PhD in Analytical Chemistry
Michelle specialises in areas related to drug development, regulatory CMC and QA. She provides regulatory strategies, compiles Module 3 documents, writes risk assessments and reviews analytical method transfer processes. With a background in chemical engineering and a PhD in Analytical Chemistry, Michelle has worked as a CMC assessor at the Swedish Medical Products Agency and as an expert in a quality working group at the EMA.
Pernilla Rådeström
Partner
MSc Chemical Engineering
Pernilla specializes in quality assurance, with experience from both the GMP and the GDP sides of product development and throughout the product life cycle. She has a background from QC and various QA positions, including roles as acting RP and QP. Pernilla received her MSc at Mälardalen University, and joined Arex after previous employment with ProPharma Group and Sofus Regulatory Affairs.
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
