HORAK Consulting
Pharmaceuticals, Medical Devices, Food & Cosmetics

Through my project management work, I have helped leading pharmaceutical and medical device manufacturers expedite their registration processes and gain a significant competitive advantage during recertification. In Switzerland, while working as "Head of Regulatory Affairs" at a family-owned company, I gained experience in the approval of critical-care pharmaceuticals by collaborating with hospital colleagues and incorporating their feedback from daily clinical practice. At TÜV-Süd (a notified body), I obtained all necessary certifications as a product specialist for Class 3 medical devices under the Medical Devices Directive (MDD). Since 2020, I have also been familiar with mRNA-based COVID-19 vaccine approval as well as iRNA approval. As an information officer, I am responsible for the labeling and formal approval of promotional materials throughout the DACH region. Through my interim management work, I have enabled many companies to achieve a smooth spin-off, a timely separation, and a successful acquisition. Through my contacts with individuals in the IT field and RA firms, I also serve as a partner for updates on regulatory intelligence and the use of AI tools in RA and the GxP industry.