We See (The Right) Things
Market Entry Solutions
U.S. Market Entry
We provide a comprehensive suite of customized services to help international life science companies transition to the US market and to understand the US FDA regulations and business practices.
Risked-Based Assessments
Risked-Based Assessments
We can provide in-depth technical expertise for the assessment of likelihood of product development, regulatory, clinical, and commercial success and return on investment.
Investor Readiness
Investor Readiness
Raising funds? We have the experience and knowledge to help our clients be investor-ready to raise capital or meet strategic partners to accelerate research discoveries to commercial success.
Life Science Entrepreneurship
Life Science Entrepreneurship
Learn to efficiently convert a research project into a commercial product through our Entrepreneurship Bootcamp. Our faculty covers investor preparedness, regulatory strategy, IP protection, and other core pillars of commercial success.
Get a deeper understanding of what we do
Our Team’s Success Speaks for Itself
Indicators
Class 1 and 2 medical device approvals by the U.S. FDA.
U.S. FDA INDs submitted and accepted on time.
Experience with over 500 drugs and therapeutics.
Dilutive capital raised for our clients through our partnering and investor relation programs.
Successful U.S. FDA IND, NDA, BLA, 505(b)1 and 505(b)2 submissions.
Successful FDA CDRH Class 1 and 2 medical device submissions.
Special Designations granted.
Connected to over 700 clinical sites.
Partnered with over 15 academic incubators and accelerators.
Only CRO hosting an Annual Life Science Partnering event at J.P. Morgan Health Care Conference.
Resources
Gaining Market Access with New MedTech Innovations: CSSi LifeSciences Partners with Market Strategy Leader, Jaunt
As a leader in US FDA MedTech regulatory affairs, we understand the complexities and challenges you face in bringing...
Trifermed and CSSi LifeSciences Join Forces to Accelerate Global Healthcare Innovation Access into the U.S. Market
Cambridge, MA & Columbia, MD — November 26, 2024 — Trifermed, founded in 2002, a strategic partnership company...
Our faculty can provide a complimentary webinar on regulatory strategies for medical devices and therapeutics.