Issue 4 2022 17 In most cases, after the development of the plan, we assist our clients through the key stage gates of development. For FDA, these are Pre-IND, IND, EoP2, Pre-NDA/BLA and NDA/BLA submission approval. We also provide support for Orphan Drug Designation (ODD), initial Pediatric Study Plans (iPSP) and any other FDA need. For most clients, we work on a project by project basis but we are sometimes asked to support our clients as their full regulatory department for a monthly retainer. Our clients are innovators, scientists and business executives of emerging pharma, biotech and medical device companies whose personal and corporate success is directly linked to regulatory success. They choose PPG-RS because we are unrivaled in the industry for helping clients achieve their regulatory milestones and business objectives. Company: ProPharma Group Website: www.ProPharmaGroup.com Jeff Antos “Our goal is to be your regulatory partner, moving you from one regulatory phase to the next, in pursuit of your corporate objectives. Located across the globe and averaging 10 years of experience, our 150 professionals use thoughtfulness and scientific acumen to consistently exceed expectations and help our clients succeed.” Matthew Weinberg, President of Regulatory Sciences Matthew Weinberg Development Process for EU Approvals Is 4 Development Process for US Approvals
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