Regulatory SERVICES
Soft Landings in U.S. Market
Let us help you land softly…
Our fully integrated and comprehensive suite of services, backed up by our unparalleled team of experts, can give your life science company a soft landing into the U.S. market, whether your company is based in the U.K., China, Germany, Japan, France, Canada, Australia, Switzerland, the Netherlands, and beyond.
Beyond our deeply experienced and knowledgeable FDA regulatory and clinical services, we provide critical connections to local industry stakeholders and U.S. market commercial strategies for medical device technologies, diagnostics, biologics and drugs.
For emerging start-up life science companies, we offer a valuable platform with access to exclusive programming and workshops designed to accelerate your expansion in the United States.
We facilitate a fully integrated and streamlined approach that’s cost effective, introduces access to the U.S. biotechnology hubs, and expands your business interest in America.
Your Trusted Partner For
The U.S. Industry Leader Offers You Services
CSSi LifeSciences was founded as a specialized contract research organization (CRO) to help life science companies advance their novel discovery to commercialization for patients who benefit most. We enable pharmaceutical and medical device companies to develop better therapies and technologies in a manner that reduces time, risks and costs.
Leveraging our vast experience and expertise in the life science industry, we also offer solutions using our ecosystem to support companies commercial development and business in the U.S.
We strive to be a personal life science value creator and partner with every company we work with in Korea, Japan, and the U.S.
Proven Team Committed to Your Success
- 80% of clients are preclinical
- Experienced in over 500 drugs
- Experienced in 300+ medical device technologies
- Connected w/ 700+ clinical sites
- KOTRA, KITA and KAPAL Partner clinical protocols
- Partner w/ 15+ academic incubators
- Only CRO hosting a Life Science Partnering event at J.P. Morgan Health Care Conference
- 100% success w/ FDA IND filings
- Experience in hundreds of clinical protocols
- Helped companies find a “Soft Landing” in the U.S.
Our Customized Services
CSSi LifeSciences can provide a comprehensive suite of customized services to help life science companies in Korea to transition to the US market and to understand the US FDA
regulations and business practices. Our
services are primarily focused on providing support to Korean companies transitioning or exporting to the US. Using our collective strength, we offer a suite of services from discovery to commercialization.
U.S. Market Entry
- In country FDA representation
- Sales, marketing and distribution
- Market assessment and strategy
- Competitive intelligence
- Pricing and reimbursement
- Talent acquisition
- Investor and pharma partner preparedness and introductions
Business and import agent
Regulatory
- Strategy and gap assessment
- FDA submissions and communications
- Feasibility risk assessment
- FDA and QMS Audit
- Advertising and promotional material review
- Medical writing
Medical Device
- Consultation and project management
- Regulatory affairs and registration
- Design and development
- Nonclinical studies
- Human factors testing
- Clinical trials
- Quality and audits
- Labeling and packaging
- Pricing and reimbursement
- Post marketing surveillance
Drug Development
- Consultation and project management
- Regulatory affairs
- Preclinical and safety toxicology consultation
- FDA Special Designations (i.e., Orphan, Fast Track)
- CMC consultation
- Labeling
- Target Product Profile
- Clinical trials
- Quality and audits