3D-PharmXchange B.V.

3D-PharmXchange is a Netherlands-based drug development consultancy and trusted partner to biotech companies, pharmaceutical organisations, and academia since 2010. We guide the development of innovative therapeutics from early discovery through clinical development, regulatory approval, and market access.

Our multidisciplinary team combines strategic expertise with hands-on execution across regulatory affairs, CMC, non-clinical and clinical development, quality and compliance, and project leadership. We work with clients to define integrated development strategies, identify critical data gaps, and design efficient non-clinical and clinical development programmes. Our expertise includes developing target product profiles, regulatory strategies, study synopses and protocols, and translating scientific objectives into robust development plans. We also support the selection and management of CDMOs and CROs to ensure efficient programme execution.

Our experience spans small molecules, including new chemical entities and generics, biologics such as monoclonal antibodies, antibody-drug conjugates and recombinant proteins, advanced therapy medicinal products (ATMPs), combination products, medical devices, and companion diagnostics.

With extensive experience engaging with the EMA, FDA, and national regulatory authorities, we provide pragmatic, science-driven solutions tailored to each development programme. By integrating scientific, regulatory, and operational expertise, we help clients reduce development risk, accelerate development, and bring safe, effective, and innovative therapies to patients.