We provide regulatory, quality, and clinical services to medical device and pharmaceutical companies at all stages of their development. We assist with products in all three medical device classes, including software products, active implantable devices, combination products, pharmaceutical products and gene therapies. Our experience is in the areas of cardiovascular, respiratory, ENT, gastroenterology/urology, OBGYN, neurology/neurodegenerative, orthopedics and metabolic diseases. Our consultancy has obtained multiple high-value regulatory milestones for our clients, such as orphan, fast track, breakthrough therapy designations and one of few granted by FDA, Rare Pediatric Disease Designation.