LifeSciences Regulatory Solutions, LLC
QNova LifeSciences is a global regulatory consulting CRO company that is powered by LifeSciences Regulatory Solutions, LLC. QNova LifeSciences encapsulates our company’s mission to: Quality – The foundation of all regulatory and commercialization services. Nova – A guiding light symbolizing innovation and new beginnings. Our name reflects the quality and innovation we bring to every partnership, while staying true to our roots of guiding companies through complex regulatory and commercialization pathways to help life science innovators succeed.
LifeSciences Regulatory Solutions, LLC
6751 Columbia Gateway Dr, Suite 300, Columbia, MD 21046, United States
What We Do
Customized strategic and innovative regulatory solutions to navigate the complex regulatory environment for drugs and medical devices.
Comprehensive suite of services to help international life science companies transition to the U.S. market and understand FDA regulations.
Full range of services across all phases of drug and medical device development, from regulatory affairs to clinical trials and market access.
Integrated project management services to support drug and medical device development from discovery to commercialization.
Strategic pathway and consulting services for drug development, including health authority meetings and submission services.
Regulatory solutions for medical devices, including consulting, planning, and submission services.
Key People
News & Updates
Join CSSi LifeSciences at the Annual Partnering Forum during the J.P. Morgan Healthcare Conference from January 8-11, 2024.
Published November 26, 2024, this article discusses the partnership between Trifermed and CSSi LifeSciences to enhance healthcare innovation access.
Published April 18, 2024, this article highlights CSSi LifeSciences' partnership with Jaunt to improve market access for MedTech innovations.
Successful FDA Submissions
CSSi LifeSciences has achieved a 100% success rate with on-time Investigational New Drug (IND) application submissions and over 250 FDA CDRH Class 1 and 2 medical device submissions.
FDA Special Designations
The company has been granted over 30 FDA Special Designations, showcasing its expertise in navigating regulatory pathways.