CSSi LifeSciences
QNova LifeSciences is a global, innovative CRO and consulting group specializing in advancing therapeutics and medical devices through development and regulatory approval. They offer customized solutions to mitigate risk, time, and expense, supporting the U.S. market goals of their clients. With extensive FDA experience, they guide companies from discovery to commercialization, ensuring high standards of quality and efficiency.
Industries
Nr. of Employees
small (1-50)
CSSi LifeSciences
6751 Columbia Gateway Drive, Suite 300, Columbia, MD 21046
Services
Regulatory strategy development, preparation of submission dossiers, agency meeting support and regulatory compliance advisory for drugs, biologics, devices and diagnostics.
Study design, monitoring, site identification and clinical operations support across early to late phase trials.
Integrated program management to coordinate regulatory, clinical and commercial activities and to accelerate product commercialization.
Fee-based accelerator offering regulatory assessments, investor readiness coaching, mentorship, partner introductions and educational webinars targeted at early-stage life science companies.
Complimentary and scheduled webinars on regulatory strategy, FDA updates, commercialization planning and investor preparedness.
Coordination with GLP-capable non-clinical CROs and management of preclinical study programs to support regulatory filings.
Regulatory strategy development, preparation of submission dossiers, agency meeting support and regulatory compliance advisory for drugs, biologics, devices and diagnostics.
Study design, monitoring, site identification and clinical operations support across early to late phase trials.
Integrated program management to coordinate regulatory, clinical and commercial activities and to accelerate product commercialization.
Fee-based accelerator offering regulatory assessments, investor readiness coaching, mentorship, partner introductions and educational webinars targeted at early-stage life science companies.
Complimentary and scheduled webinars on regulatory strategy, FDA updates, commercialization planning and investor preparedness.
Coordination with GLP-capable non-clinical CROs and management of preclinical study programs to support regulatory filings.
Expertise Areas
- Regulatory submission strategy and FDA interactions
- Medical device regulatory affairs and QMS compliance
- Clinical trial design and site management
- CMC and non-clinical strategy
Key Technologies
- Medical devices
- In vitro diagnostics (IVD)
- Biologics and therapeutic drugs
- Cell and gene therapies
News & Updates
CSSi LifeSciences partners with Australian states to facilitate entry into the US healthcare market, supporting Australian life science companies.
Class 1 and 2 medical device approvals by the U.S. FDA
Achievement in medical device approvals.
U.S. FDA INDs submitted and accepted on time
Achievement in IND submissions.
Experience with over 500 drugs and therapeutics
Extensive experience in drug development.
Successful FDA submissions including IND, NDA, BLA, 505(b)1 and 505(b)2
Track record of successful regulatory submissions.
Connected to over 700 clinical sites
Extensive clinical trial network.
CSSi LifeSciences partners with Australian states to facilitate entry into the US healthcare market, supporting Australian life science companies.
Class 1 and 2 medical device approvals by the U.S. FDA
Achievement in medical device approvals.
U.S. FDA INDs submitted and accepted on time
Achievement in IND submissions.
Experience with over 500 drugs and therapeutics
Extensive experience in drug development.
Successful FDA submissions including IND, NDA, BLA, 505(b)1 and 505(b)2
Track record of successful regulatory submissions.
Connected to over 700 clinical sites
Extensive clinical trial network.