Innovative Regulatory Science Group, Inc. (IRSG) is a worldwide strategy consulting firm specializing in early development and regulatory advice to the biologic, drug, and medical device industries. Our staff of regulatory compliance experts have decades of experience in helping our clients move their products forward with respect to their investments in clinical and non-clinical development programs. We provide strategic support concerning regulatory affairs on a global, regional or national level. From orphan drugs and biosimilars to AI-enabled medical devices, we manage and support large, complex and unpaved projects from pharmaceutical companies, seasoned or start-ups. IRSG prepares packages for regulatory submissions to ensure alignment and compliance with FDA, EMA, Health Canada, or local and regional registration requirements as well as with your company policies. We have been authoring successful regulatory applications and offering efficient and timely submissions. Whether you need an application from start to finish or a detailed development plan, we support you and your team. We help with the big decisions that will save your company both time and money. Some of the services we offer: • early interaction meetings • US/EU orphan drug designation • breakthrough therapy • IND & CTA