Alexander Wenzel

Alexander is a trusted advisor who excels in guiding technology clients through the intricate landscape of EU regulatory compliance. He seamlessly integrates expertise in Life Sciences regulatory and data privacy requirements. The scope of his product practice covers all life cycles of (in vitro) medical devices, (advanced therapeutic) medicinal products and digital products such as wellness apps. He advises clients on all regulatory aspects governing their product including classifications, clinical trials, GCP and GMP investigations, regulatory market exclusivities, marketing authorization applications and conformity assessment procedures. He also has extensive experience counseling organizations on data privacy matters. Alexander has assisted clients with setting up privacy compliance frameworks, addressing cybersecurity incidents, resolving investigations by competent authorities and with navigating sector specific requirements governing personal health data. · Simmons & Simmons