Gouya Insights is an independent, science-driven clinical development and regulatory consulting company supporting innovative life-science products from early strategy through clinical execution. We specialize in the clinical, regulatory, and strategic development of medicinal products, medical devices (including SaMD), and in vitro diagnostics, with a strong focus on complex, high-risk, and first-in-class programs. Our core expertise spans Target Product Profiles (TPPs), Clinical Development Plans (CDPs), study design, regulatory strategy, and operational oversight across the EU, US, and global pathways. Founded and led by PD Dr. Gouya with extensive background in pharmaceutical medicine, clinical research, and regulatory affairs, Gouya Insights operates as a boutique, hands-on partner rather than a standard CRO. We integrate scientific depth, regulatory intelligence, and pragmatic execution, often stepping into extended team roles for biotech companies, start-ups, and academic spin-offs. Our therapeutic experience includes hematology/oncology, immunology, gastroenterology, neurology, cardiovascular disease, and women’s health, with a strong track record in early clinical development, adaptive study designs, and regulator interactions (EMA, FDA, national authorities, notified bodies). At our core, Gouya Insights stands for: Scientific rigor and credibility Regulatory foresight and compliance Operational excellence with senior oversight Trusted partnership from concept to proof of value In short, we help innovators translate promising science into clinically and regulatorily viable development programs—efficiently, credibly, and strategically.
As founder of Gouya-Insights GmbH & Co KG (www.gouya-insights.com), Ghazaleh provides clinical development leadership to biotechnology, and medical device/ diagnostic companies to address the challenges of clinical product development and regulatory compliance. The cornerstone of this success is an expert team of scientists and clinical experts in life science research. It is this insight that enables Gouya Insights to guide clients from discovery through testing, clinical trials, regulatory approvals and ultimately to market in the most efficient manner.
Ghazaleh Gouya Lechner is board certified in internal medicine, cardiology and clinical pharmacology, and has more than 20 years of experience in clinical research. After being awarded the title of Associate Professor of Internal Medicine at the Medical University of Vienna, she joined a global CRO as Medical Director. Ghazaleh has been involved in a number of product development processes where she has made a significant contribution to project strategy and protocol development, identifying the best strategy for the right patients at the right site through to completion of marketing authorization documentation.
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International markets (regions) of interest
East Asia (e.g. China, Japan)North America (USA & Canada)Scandinavia (Nordics)