Gouya Insights GmbH und Co KG

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.