Robert E. Zoubek

Principal Consultant
Granzer Regulatory Consulting & Services, Germany
Dr Robert Zoubek, joined Granzer Regulatory Consulting & Services in 2013. Robert supports large, medium and small companies in all questions concerning regulatory requirements and expectations for drug substance and drug product development, manufacturing, quality control, comparability of gene and cell therapies, live therapeutics and other product types. He has in depth knowledge in European and US requirement with regard to IMPD/ IND, MAA, BLA. He supports scientific advice, protocol assistance with EMA and EU national agencies and FDA meetings and the preparation of briefing documents. Robert has more than 20 years of experience in the development of pharmaceuticals, especially biologics and gene and cell therapies. He has 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 Robert E. Zoubek is currently speaking at

Pharma

Stability & Shelf Life of Biologics
16 - 18 May 2022
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.

Pharma

Quality Requirements for Biotech Products
13. - 15. December 2021
Online Live Stream | 9:00 – 17:00 CET
This practical course provides an in-depth understanding regulatory landscape for national CTA procedures.

Pharma

Cell & Gene Therapy Products – CMC & Quality Requirements
13 - 15 September 2022
Barcelona, Spain | Online Live Stream 09:00 CEST – 15:00 CEST
This unique course provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance & quality concerns.

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Robert E. Zoubek
Principal Consultant
Granzer Regulatory Consulting & Services, Germany
Dr Robert Zoubek, joined Granzer Regulatory Consulting & Services in 2013. Robert supports large, medium and small companies in all questions concerning regulatory requirements and expectations for drug substance and drug product development, manufacturing, quality control, comparability of gene and cell therapies, live therapeutics and other product types. He has in depth knowledge in European and US requirement with regard to IMPD/ IND, MAA, BLA. He supports scientific advice, protocol assistance with EMA and EU national agencies and FDA meetings and the preparation of briefing documents. Robert has more than 20 years of experience in the development of pharmaceuticals, especially biologics and gene and cell therapies. He has 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.
Robert E. Zoubek
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