Based in 14 different countries, our teams of local experts will enable your expansion into the second largest pharmaceutical market.
The European network of regulanet® Switzerland is a group of pharmaceutical experts from 14 European countries focused on establishing Quality Systems and Licenses for pharmaceutical companies. Initially founded by Dr. Jürgen Regenold in 2001, regulanet® offers services to pharmaceutical companies seeking expansion into the EU.
Dr. Ingrid Huber-Strubl, founder and CEO of ARAC, is a pharmaceutical industry professional with more than 30 years of experience. In her career, she has supported a lot of pharmaceutical companies getting their licenses granted by the national competent authorities in Austria by building up the Quality Management System. Dr. Huber-Strubl has a PhD degree in Biochemistry and Zoology from the University of Vienna and is a member of Megra.
Ludwig Everaert is the CEO of Archemin, which he has founded in 1999. He has a combined experience of 24 years in the pharmaceutical industry. Ludwig earned a degree in Pharmaceutical Sciences and a Master degree in Business Administration. He is a member of the Belgian Industrial Pharmacists Association, Association of Clinical Research Professionals, the Belgian Regulatory Affairs Society and the European Medical Writers Association.
Gitte Alstrøm is CEO and Co-owner of A-consult a/s founded in 1983. She has 13 years of experience in the pharmaceutical industry and has supported a wide variety of companies with solutions within Quality Assurance, Regulatory Affairs and Pharmacovigilance. Combining her experience in project management and business development with the Life Science industry experience gives her an important client insight.
Béatrice Simon-Vagneur, Pharm. D., is the Managing Director and founder of DextReg. She has served as Regulatory Affairs Manager at both Galderma International and at GlaxoWelcome France. Furthermore, she has worked as an independent consultant based in Portugal and in Brazil. Simon-Vagneur passed her doctorate in pharmacy at the University of Angers, France. She is currently the Deputy Qualified Person of two Exploitant companies in France.
Sonja Rüdele, BA, is the Quality Management Representative of Dr. Regenold GmbH. She is responsible for the company’s quality management system which she set up after joining Dr. Regenold GmbH in 2001. Sonja Rüdele holds a Bachelor’s degree in nutrition and hygiene technologies with a focus on quality management and production hygiene. Sonja supports clients in building up their Quality Management System and in receiving the required licenses.
Nicola Hardman is the Chief Operations Officer at JensonR+ Limited. She is a pharmaceutical industry professional with formal qualifications in Regulatory Affairs and pharmaceutical ethics. Having worked in the industry for more than 18 years, she offers extensive experience in market access, medical information, regulatory affairs, Quality Assurance, pharmacovigilance and R&D. She is a member of TOPRA, PIPA and the Royal Society of Biology.
Joanna Mania, PhD, is the Department Director of Regulatory Affairs and Quality at DADA Consultancy. Next to her extensive experience in laboratory management she is an experienced pharmaceutical development project manager. Joanna furthermore specializes in setting up quality systems, quality agreements and auditing. Within DADA’s quality management system, Joanna is main responsible for Quality Assurance. She has earned a PhD in forensic chemistry.
Maria Nilsson Hagberg, Managing Director at Pharm Assist, is a Quality and Regulatory Affairs specialist with 10+ years of experience in regulatory affairs. Her experience includes setting up Quality Systems, handling complaints and deviations, reviewing quality agreements and performing self-inspections. She also specializes in pricing and reimbursement of pharmaceuticals. Maria Nilsson Hagberg has earned a Master degree in Pharmacy from the University of Uppsala, Sweden.
Catarina Vieira, Pharm. D. and Post-Graduated in Regulation and Evaluation of Medicines and Health Products by the Faculty of Pharmacy from Coimbra and Lisbon University is the Managing Director of PTR Pharma Consulting, Lda. With 15+ years of experience as Regulatory Affairs and Quality specialist, she has solid expertise in Regulatory strategy, Liaison with authorities, Marketing Authorization and Clinical Trial applications, GMP and GDP audits, WDL applications. She has supported a lot of pharmaceutical companies in accessing the Portuguese market.