CSSi LifeSciences™ Drug & Medical Device Commercialization & Medical Device CRO Our goal is to ensure a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. We enable faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. Unparalleled Success from Discovery to Commercialization • Commercialized over 500 new drugs, biologics, medical devices, and in-vitro diagnostics • Over 250 medical device 510(k) Class 1-3 submissions with 100% success. • Extensive Orphan, “First in Class,” and “First In” Indication success. • Reduced time to approval by over 600 days. • Over 100 NDA, ANDA and BLA submissions, with 96% success. • Greater than 60 EMA CHMP Marketing Authorizations. • SmartStudyTM design and feasibility assessments enhanced study efficiency and success and reduced protocol amendments by over 50%. CSSi LifeSciences Medical Device CRO has experience navigating regulations in over 100 countries. Often companies struggle with the pathways for a medical device from design to commercialization because of the ambiguity and complexity of the process. Regulations and requirements change frequently and vary by notifying bodies, country, level of risk (i.e., Class 1-3), specific product claims, and intended use. Our diverse team has many years of medical device commercialization experience, with the knowledge that goes beyond published guidance, documents and initiatives. CSSi LifeSciences Medical Device CRO aims to impact the timeline of regulatory clearance and increase profitability.