Meet our experts

Quality Assurance

With Arex, you have a full suite of expertise at your fingertips. 

Alina Makedonska

Based in Lund, Sweden

 MSc Industrial Biotechnology

Azadeh Khoshegir

BSc Biomedical Science

Henrik Svederud

Based in Lund, Sweden

MSc Chemical Engineering

Isak Simón

MSc Pharm

Juho Bah

PhD in Organic Chemistry

Katarina Alheim

Partner, Chief Quality Officer

PhD in Neurochemistry and Neurotoxicology

Maria Flärd

Based in Lund, Sweden

Licentiate, Analytical Chemistry

Martina Johannesson

PhD Medical Science

Michelle Co

Partner

PhD in Analytical Chemistry

Nelly Fransén

Partner
Based in Lund, Sweden

 PhD in Pharmaceutical Sciences

Pernilla Rådeström

Partner

MSc Chemical Engineering

Sozyar Karim

MSc Pharm

Viola Hassinen

Based in Lund, Sweden

MSc Pharm

Alina Makedonska

Based in Lund, Sweden

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.

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.

Henrik Svederud

Based in Lund, Sweden

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.

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

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

Based in Lund, Sweden

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. Maria’s latest position was at Prevas, and her degree in Analytical Chemistry comes from Lund University.

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.

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.

Nelly Fransén

Partner
Based in Lund, Sweden

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.

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.

Sozyar Karim

MSc Pharm

Sozyar works with pharmacovigilance and quality assurance. In parallel with her studies at Uppsala University she worked with GMP processes at Svensk Dos AB. Sozyar did her Master’s Thesis at the Swedish Medical Products Agency.

Viola Hassinen

Based in Lund, Sweden

MSc Pharm

Viola specializes in quality assurance, focusing on Good Distribution Practice (GDP) and Good Automated Manufacturing Practice (GAMP). Viola assists our clients with wholesaler distribution authorization applications and computerized system implementation, taking on the role as Responsible Person GDP and other quality assurance tasks. She is a Pharmacist educated at Uppsala University and the University of Navarra. She previously worked with Quality Assurance at Teva Sweden.

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.