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Ronald Ullers

Regulatory Affairs CMC Senior Consultant


Ronald Ullers

Experience

With a PhD in Molecular Microbiology from VU Amsterdam, Ronald joined hVIVO consulting  in 2015 as an RA-CMC consultant before becoming a senior consultant almost a year later. ​

Expert in regulatory demands (focus on CMC) for global registrations of biological products, incl. recombinant proteins, vaccines, and ADCs​

Skilled in developing RA(-CMC) strategies, regulatory submissions, and liaising with US and EU agencies​

Authored scientific advice/Pre-IND briefing packages and served as Sponsor representative during advice procedure

Contributed Articles

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Case StudyScientific PublicationFactsheetBlog

A New Frontier in Respiratory Health: Next-Gen Human Challenges Explained

Case StudyScientific PublicationFactsheetBlog

Beyond Traditional Studies: The New Era of Respiratory Virus Human Challenge Models

Scientific PublicationFactsheetBlog

The Future of Virology: How Next-Gen Human Challenge Models are Breaking Barriers