Robert is Executive Consultant at Granzer Regulatory Services and advises clients on CMC from early development up to marketing authorization for Europe and USA. He has 20 years of experience in development of biologics and biosimilars. Robert has in-depth knowledge in protein and ATMP analytics, their characterization and in the design and execution of comparability studies. Moreover, as he has frequent exchange with agencies worldwide, he precisely understands the agencies´ most current regulatory expectations.
Until he joined Granzer Regulatory Services, Robert worked as Director Scientific Affairs at Formycon/Germany, a leading developer of Biosimilars for regulated markets.
Robert earned the PhD from the University of Erlangen-Nuremberg for his research on pharmaceutical peptides and he was awarded Master of Business Administration from the University of Manchester. He also holds a MSc from the University of Munich.
Events/Masterclasses Dr. Robert E. Zoubek is currently speaking at
Pharma
CMC Analytical Comparability: Methods & Strategies for Biologics
18 – 19 February 2025
Rome, Italy
Join our CMC Analytical Comparability training led by experts to understand principles of protein structure and comparative analytics.
With the increasing complexity of new cell & gene therapies, as well as a rapid growth of these products in the development, unique challenges have emerged especially in the area of manufacturing and control.
The purpose of this Stability & Shelf Life of Biologics Training Course is to get comprehensive overview on stability and shelf-life regulatory landscape.
Stability & Shelf Life of Cell & Gene Therapy Products
Online Live Stream
This 2-day practical workshop is focused on ATMPs & brings a comprehensive overview on stability and shelf-life regulatory landscape, as well as analytical methods for stability assessment of your cell & gene therapy products.
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Robert is Executive Consultant at Granzer Regulatory Services and advises clients on CMC from early development up to marketing authorization for Europe and USA. He has 20 years of experience in development of biologics and biosimilars. Robert has in-depth knowledge in protein and ATMP analytics, their characterization and in the design and execution of comparability studies. Moreover, as he has frequent exchange with agencies worldwide, he precisely understands the agencies´ most current regulatory expectations.
Until he joined Granzer Regulatory Services, Robert worked as Director Scientific Affairs at Formycon/Germany, a leading developer of Biosimilars for regulated markets.
Robert earned the PhD from the University of Erlangen-Nuremberg for his research on pharmaceutical peptides and he was awarded Master of Business Administration from the University of Manchester. He also holds a MSc from the University of Munich.
