PhaRA

PhaRA is a boutique consultancy firm with 20+ years successful track record in submission and approval of regulatory applications and interactions with regulators. We provide a personal and regulatory-wise service for the development and life cycle management of innovative products to client companies ranging from start‐up biotechs to headquarters and Benelux affiliates of multinational pharma companies. PhaRA is committed to meet client regulatory milestones in drug development, bringing medicinal products, devices or combination to patients and keeping approved products on the market. Spearheading in oncology, immunology, neuroscience, infectious disease and vaccines, other unmet medical need areas. By focusing exclusively on regulatory affairs, PhaRA can offer in-depth knowledge, insight, skills, and expertise covering end2end scope from setting global strategy to writing regulatory, CMC and medical documents, managing global labeling and executing regulatory procedures in EU and with WHO across the product life cycle. We can operate as an independent driver of specialized regulatory activities, act as a fully-staffed regulatory affairs department including Head-of-RA-as-a-service, or complement existing resources at headquarters or BENELUX affiliates. Our Senior Advisors are key RA opinion leaders (exPDCO/CHMP/ SAWP/COMP members and ex-Sr VPs Global RA in large pharma). always reliable, resourceful, respectful, regulatory-wise and regulatory-proof