Lisa Holthaus
Senior Consultant at Pharmalex
Based in Munich, Germany
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Seniority
Manager
Department
General Business & Management
Location
Munich
Industry
Pharmaceutical Manufacturing
Company size
1.9K
Contact information
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l•••••••@pharmalex.com
Phone
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Background
About Lisa Holthaus
Experienced Senior Regulatory Consultant with specialized expertise in nonclinical development strategies for biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs), bringing comprehensive knowledge in regulatory affairs. Focused on developing critical regulatory documentation including e.g, INDs, IMPDs, IBs, ODDs, PIPs and Scientific Advice Briefing Documents, with proven capabilities in navigating complex regulatory landscapes for EMA, FDA, and national authorities. Deep technical understanding of nonclinical study design, data interpretation, and strategic regulatory planning, particularly for early-stage product development.
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