Orphix Consulting Gmbh

Orphix is a regulatory consulting group founded in 2002, that focuses on supporting the development of orphan drugs in Europe and US. We provide a flexible service, expert guidance and support our clients with their regulatory strategy, procedures and electronic submissions. Orphix provides a boutique tailored consulting service of high level scientific and regulatory expertise mainly to small and medium-sized (SME) biotech companies developing highly innovative products for the prevention or treatment of rare diseases. Our regulatory services include advice on nonclinical and clinical aspects, both from the perspective of drug development strategy and regulatory requirements. The core expertise of our regulatory consultants includes orphan drugs, scientific advice meetings (European Medicines Agency and national regulatory agencies), electronic submissions and paediatric investigational plans. Our experienced multilingual regulatory consultants work closely with several regulatory agencies and develop long-term partnerships with clients located mainly in North America and Europe. We bring passion, deep expertise and unfaltering dedication to ensure quality, excellence with a strong focus on the client´s success. Our mission is the advancement of innovative medicines in the best interest of patients.