CSSi LifeSciences

CSSi LifeSciences provides regulatory solutions to pharmaceutical and medical device companies. The company's goal is to ensure a successful and expeditious pathway to commercialization for clients' drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. CSSi LifeSciences has an impressive track record, having commercialized over 500 new drugs, biologics, medical devices, and in-vitro diagnostics, and successfully completed over 250 medical device 510(k) Class 1-3 submissions with 100% success. They have also excelled in areas such as Orphan, “First in Class,” and “First In” Indication success, reducing time to approval by over 600 days, and achieving over 100 NDA, ANDA and BLA submissions with 96% success. CSSi LifeSciences Medical Device CRO expertise extends to navigating regulations in over 100 countries. With a deep understanding of the complexity and ambiguity surrounding medical device commercialization, they focus on impacting the timeline of regulatory clearance and increasing profitability. Overall, CSSi LifeSciences stands out for its extensive experience, successful track record, and global reach in providing regulatory solutions for pharmaceutical and medical device companies.