Linda Thunell

MSc Tox
Founding partner, CEO


During her 25 years in the pharma­ceutical industry Linda has held various executive positions, and between 2002 and 2019 she was the founder and CEO of Sofus Regulatory Affairs AB. She has also worked as Head of Regulatory Affairs in pharma companies and as assessor at the Swedish Medical Products Agency.
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Staffan Thunell

BSc Economics and BA
Founding partner, CFO


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.
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Erik Hedner

PhD Med Chem and MBA
Founding Partner, Director Drug Development


Erik specialises in areas related to drug development and regulatory CMC. After a PhD in Medicinal Chemistry he worked as a CMC assessor at the Swedish Medicinal Products Agency. He has since held various expert positions within pharma consulting, primarily with a focus on CMC in phase I-III projects.
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Lovisa Rosenquist

BSc Mol Cell Biol
Founding partner, Director Post-Marketing Projects


Lovisa is a senior regulatory project manager with extensive experience from leading positions at consult­ancies, managing Nordic as well as global projects. She specialises in assisting companies with market entry and product launch activities. Lovisa started her career at the European Medicines Agency (EMA).
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Katarina Alheim

PhD in Neurochemistry and Neurotoxicology
Partner, Chief Quality Officer


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.
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Kristin Augustsson

MSc Pharm


Kristin is on our regulatory and pharmacovigilance team. She is a pharmacist graduated from Uppsala University who brings with her experience from working at the Swedish Association of the Pharmaceutical Industry (LIF). There she reviewed data on medicines published on FASS.se and assisted with analyzing clinical trials data for covid-19 vaccines.
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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.
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Tamara Behnan

MSc Pharm


Tamara is a specialist in regulatory affairs CMC and QA. She has, in addition to several years in regulatory CMC, a broad experience of lifecycle management, stakeholder management, deviation management, change management and GMP compliance. Before joining Arex she was with AstraZeneca. Tamara's MSc degree in Pharmacy comes from Uppsala University.
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Linnea Brodin

BSc Business and Economics


Linnea is our Finance Assistant. She has a BSc in Business and Economics from Södertorns University and has previously worked in the accounts payable department at Huddinge Kommun.
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Michelle Co

PhD in Analytical Chemistry
Partner


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.
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Eva Dahlin

MSc Pharm


Eva Dahlin is a specialist in strategic and operational regulatory affairs. She is experienced in launch management, regulatory project and lifecycle management, as well as other functions essential to successful commercialisation in the Nordics and in other European regions. Eva has for over 15 years held leading roles in small to large pharma companies such as Alexion, Mylan (now Viatris) and CSL Behring. Her degree is from Uppsala University.
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Catarina Edfjäll

PhD in Biochemistry
Senior Advisor
Based in Basel, Switzerland


Catarina has more than 25 years' experience in global regulatory affairs and regulatory intelligence. She has held leadership roles within CSL Behring, Roche, Celgene (now BMS) and other international pharma and biotech companies. She has been responsible for the marketing authorization of over 20 innovative products and new indications (including for orphan drugs), reorganized global regulatory affairs departments and led successful health authority negotiations.
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Rolf Eriksson

PhD in Biomedicine
Partner


Rolf specializes in global regulatory affairs and regulatory CMC. He holds a PhD in Biomedicine and came to us from a position as Regulatory Affairs Director at Rare Thyroid Therapeutics. Prior to that he was a Managing Consultant, Director and Partner at Sofus Regulatory Affairs AB. Rolf has also worked as Regulatory Affairs Officer at Orion Pharma.
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Olle Fahleson

MSc Bioentrepreneurship
Partner


Olle specializes in regulatory affairs and CMC. He has been working with various European and global markets, gaining experience in regulatory project management and submissions for pre- and post-marketing phases of the product life-cycle. Olle is also experienced with ethical review of promotional materials within the Nordics. After obtaining a Master’s degree in Bioentrepreneurship at the Karolinska Institute, he worked at a global pharmaceutical company as a regulatory CMC manager.
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Anastasia Flanagan

PhD Linguistics


Anastasia is Marketing Manager with over 12 years of experience in marketing and business development within life sciences. She worked for hearing implant manufacturer Cochlear; following that, she was with IPSEN AB. She holds a PhD in Linguistics and a BA in Finance.
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Maria Flärd

Licentiate, Analytical Chemistry
Based in Lund, Sweden


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.
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Nelly Fransén

PhD in Pharmaceutical Sciences
Partner
Based in Lund, Sweden


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.
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Viola Hassinen

MSc Pharm
Based in Lund, Sweden


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.
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Josephine Ingemarsson

MSc Pharm
Partner


Josephine is a regulatory affairs professional specialising in regulatory lifecycle management, both on a global and on a local level. Beside that she has strong experience in conducting complete user readability tests and running serialization projects. She previously worked at ProPharma Group, Sofus Regulatory Affairs and Kronans Apotek, with degrees in Pharmacy from Uppsala University and Sydney University.
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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.
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Josefin Jönsson

MSc Pharm
Partner


Josefin specializes in regulatory CMC and global regulatory affairs. She has extensive experience of working with pharmaceutical companies, focusing on coordination of CMC documentation for EU and US submissions from Phase I to new drug applications and life cycle management. Josefin started her career at the Swedish Medical Products Agency, and worked on early-phase projects at Fresenius Kabi.
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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.
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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.
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Ann Kjellgren

MSc Media & Communication
Communications Director


Ann is a professional in branding and communication with strong experience of leading teams and developing effective strategies. Most recently she worked as Client Service Director at the global agency Up There, Everywhere. She is a graduate of Uppsala University.
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Tove Leire

MSc Pharm
Partner
Based in Gothenburg, Sweden


Tove is a regulatory affairs professional specialising in regulatory lifecycle management. She has broad experience covering all aspects of post-approval activities, such as product information handling, artwork creation, market launch and variation submissions on the Nordic market. She is also experienced with reviewing promotional materials and writing SOP's and Work Instructions for the regulatory area. She has an MSc in Pharmacy from Uppsala University, and has worked at ProPharma Group, Sofus Regulatory Affairs and LIF.
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Ellinor Lindholm

MSc Medical Biotechnology


Ellinor is a regulatory affairs expert with a strong focus on global projects in Regulatory CMC. She has worked with regulatory compliance, regulatory submissions, stakeholder relations and regulatory project management. Ellinor’s Master’s degree comes from KTH in Stockholm, and her most recent role was at AstraZeneca.
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Karin Leoson (née Nylander)

MSc Pharm
Partner


Karin is experienced in pharmacovigilance, predominantly from the Nordic markets. Her experience extends from case management to database entering and MedDRA coding, and she is also skilled in quality management systems for pharmacovigilance. Before joining Arex she worked as a Safety Data Management Specialist at Pfizer, and as a Regulatory Affairs and Pharmacovigilance Consultant at ProPharma Group and Sofus Regulatory Affairs.
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Alina Makedonska

MSc Industrial Biotechnology
Based in Lund, Sweden


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.
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Amra Mekic

BSc Pharm


Amra works in our regulatory and pharmacovigilance teams, and with review of promotional materials. She is a pharmacist from Linneaus University and also has an MA in Communication. She has previously worked as Manager of a health clinic and Pharmacist.
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Alice Olsson

MSc Pharm


Alice is part of our regulatory affairs team, working with local regulatory affairs for the Nordic markets. She is a pharmacist with a degree from Uppsala University. Prior to joining Arex, Alice worked at Kronans Apotek.
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Camilla Österlund

PhD in Medicine
Based in Tampere, Finland


Camilla provides pharmacovigilance and regulatory affairs support to our clients. She has a PhD in Medicine from Umeå University. Her previous work experience includes working as a pharmacist, as well as in a variety of pharmacovigilance functions at Niconovum. Camilla speaks fluent Finnish.
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Minh Pham

MSc Formulation and Biopharm


Minh is a senior consultant in regulatory affairs and CMC. He has an MSc in Formulation - Pharmatechnology and Biopharmacy, but also in International Strategy and Marketing. He held roles at Galderma and at AstraZeneca, most recently as Global Regulatory CMC Manager.
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Anna Ravnefjord

MSc Biology


Anna Ravnefjord is a senior professional in global regulatory affairs, with deep and long-ranging experience in clinical trials at Phase 1, 2a and 2b; IND applications and interactions with EU and US regulatory authorities. She is highly skilled in marketing authorisation applications and license maintenance activities for both development products and mature brands. Anna has held senior regulatory and research roles at AstraZeneca. She is a published scientist and holds a degree from Gothenburg University.
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Pernilla Rådeström

MSc Chemical Engineering
Partner


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.
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Susanne Schuurman

MSc Health Economics
Partner, Head of Market Access


Susanne specializes in strategic market access and HTA. Her expertise includes strategic landscape assessments, development of reimbursement dossiers and stakeholder interactions. She has experience as project manager for a variety of strategic market access projects, from phase II to post-marketing. She has previously worked at a global consultancy firm.
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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.
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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.

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Unnur Sverrisdottir

MSc Pharm


Unnur specializes in market access and regulatory affairs. Her primary focus is on market access for the Nordic markets and ethical review of promotional materials. Unnur is from Iceland and received her degree in Pharmaceutical Sciences from the University of Iceland. She previously worked at Teva/Actavis and Alvogen.
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Emelie Terenius

BSc Business and Economics
Partner


Emelie is our Finance Manager who joined Arex after working at KPMG, where her most recent position was Project Coordinator International Tax. Emelie has also worked as a tax officer at the Swedish Tax Agency and as Head of Tax and Legal at a non-profit organisation.
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Minna Zakrisson

MSc Pharm


Minna is on our Pharmacovigilance team, supporting clients with medical information and timely reporting of adverse events. She most recently worked as a Clinical Research Associate at Parexel, and before that held roles in several pharmacy chains. Minna holds an MSc in Pharmaceutical Sciences from Uppsala University.
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