Dr Robert Zoubek, joined Granzer Regulatory Consulting & Services in 2013. Robert supports large, medium and small sized companies to meet regulatory requirements and quality expectations for product development, manufacturing, quality control, comparability of gene and cell therapies. He frequently supports scientific advices, protocol assistance with EMA and EU national agencies and FDA meetings and was involved in numerous MAA/BLA filings and approvals. As such he has in depth knowledge in European and US requirements regarding IMPD/ IND, MAA, BLA.
Robert has more than 20 years of experience in the development of pharmaceuticals, especially biologics and gene and cell therapies. He has a strong expertise in product development and manufacturing, process development and validation, analytical method development and validation, and comparability studies.
Until he joined Granzer Regulatory Consulting & Services, Robert worked in several positions at Formycon and GlycoForm in the UK.
Events/Masterclasses Dr. Robert E. Zoubek is currently speaking at
Barcelona, Spain | Online Live Stream | 9:00 CET – 17:30 CET
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.
Barcelona, Spain | Online Live Stream | 9:00 CEST -15:00 CEST
The purpose of this Stability & Shelf Life of Biologics Training Course is to get comprehensive overview on stability and shelf-life regulatory landscape.
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Dr Robert Zoubek, joined Granzer Regulatory Consulting & Services in 2013. Robert supports large, medium and small sized companies to meet regulatory requirements and quality expectations for product development, manufacturing, quality control, comparability of gene and cell therapies. He frequently supports scientific advices, protocol assistance with EMA and EU national agencies and FDA meetings and was involved in numerous MAA/BLA filings and approvals. As such he has in depth knowledge in European and US requirements regarding IMPD/ IND, MAA, BLA.
Robert has more than 20 years of experience in the development of pharmaceuticals, especially biologics and gene and cell therapies. He has a strong expertise in product development and manufacturing, process development and validation, analytical method development and validation, and comparability studies.
Until he joined Granzer Regulatory Consulting & Services, Robert worked in several positions at Formycon and GlycoForm in the UK.
