Our Quality Assurance experts in Life Sciences

Quality Assurance

At Arex Advisor, our strength lies in the deep expertise of our Quality Assurance specialists. With decades of combined experience across the pharmaceutical, biotech, and medtech sectors, our team offers both strategic guidance and hands-on operational support. From designing and implementing robust Quality Management Systems (QMS) to navigating EU GMP/GDP compliance and acting as Qualified Persons (QP), our experts ensure that your product development and distribution processes meet the highest regulatory standards.

Whether you’re preparing for regulatory inspections, managing complex CAPA processes, or scaling your QA function across regions like the EU, UK, or Switzerland, our consultants bring knowledge and tailored solutions to every challenge.

Portrait of Nelly Fransen Arex Advisor

Nelly Fransén

Partner
Head of Development & QA

PhD in Pharmaceutical Sciences

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Anemona Doko

MSc Pharm

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Henrik Svederud

MSc Chemical Engineering

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Isak Simón

MSc Pharm

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Katarina Alheim

Partner
Chief Quality Officer

PhD in Neurochemistry and Neurotoxicology

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Maria Flärd

Licentiate, Analytical Chemistry

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Martina Johannesson

PhD Medical Science

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Michelle Co

Partner

PhD in Analytical Chemistry

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Pernilla Rådeström

Partner

MSc Chemical Engineering

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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.

Anemona Doko

MSc Pharm

Anemona specialises in Quality Assurance. She has a master’s degree in Pharmaceutical Science from University of Gothenburg. Prior to joining Arex, Anemona worked as a R&D & QA manager in the pharmaceutical industry.

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.

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.