ASPHALION
Izabela Bedziak is a highly experienced professional in the field of scientific and regulatory affairs, currently serving as the Scientific & Regulatory Affairs Manager at ASPHALION since May 2018. With a robust background in CMC preparation, regulatory submissions, and strategic regulatory advice, Izabela has demonstrated expertise in managing marketing authorization applications across various global markets, including the EU and US. Prior to this role, Izabela held positions at Aspen Pharma and GSK, where responsibilities included the timely preparation of registration dossiers and international regulatory submissions. Academic qualifications include a Master's degree in Pharmacy from Poznan University of Medical Sciences, complemented by exchange studies at the University of Ljubljana and Semmelweis University.
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ASPHALION
ASPHALION is an International Scientific and Regulatory Affairs consultancy firm based in Barcelona and Munich.They offer comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies.Since 2000, we have consistently grown and now have over 70 professional consultants with backgrounds inLife sciences (Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Medicine and Veterinary Medicine). Their consultants are experts in their field and are in direct contact with EU agencies (EMA and NCAs) for the development and implementation of new regulatory standards.Asphalion provides a global range of services, for global clients. Their services range from early development, throughout the registration, until marketing and post-commercialization phases of your product.