Commercialization
U.S. Commercialization
The U.S. healthcare market is complex, fragmented, and heavily regulated. Entering such a landscape can be confusing, time-consuming, and expensive. Working with CSSi LifeSciences reduces the risks and costs of entering the U.S. market while ensuring that all regulatory and oversight requirements are met in a timely and professional manner.
Leveraging our vast experience and expertise in the life science industry, we offer solutions using our ecosystem to support companies’ commercial development and business interests in the U.S. CSSi LifeSciences has the industry experience and knowledge to connect companies to strategic investors and resources that can rapidly accelerate research, discovery, and commercialization.
Our fully integrated commercialization services can help international companies establish a “soft landing” in the U.S. market while maximizing your product’s chances of success.
CSSi LifeSciences can provide comprehensive, customized services to help international life science companies transition to the U.S. market and to understand the U.S. FDA regulations and business practices.
Using our collective strength, we offer a suite of services from discovery to commercialization, including:
- Investor readiness and presentations
- 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 services
We strive to be a personal life science value creator and partner to every company we support.
Capital Access and Strategic Partners
We enable early stage and emerging growth companies to connect with resources and specialized services to expedite technology development and to successfully traverse the “Valley of Death” to drive value and accelerate your research discovery to commercialization.
CSSi LifeSciences™ has the industry experience and knowledge to connect companies to strategic investors and resources that can rapidly accelerate a research discovery to commercialization. We have helped our clients raise over $700M USD of capital over the past three years1.
1CSSi LifeSciences is not a licensed broker dealer or investment bank and receives no success fees, commissions or other forms of monetary benefit resulting from capital raising, other than our usual and customary professional service fees.
Commercial Support
Commercial support for early technology development is essential to determine the therapeutic areas, indications, or medical procedures that are commercially viable. The design of a competitive Target Product Profile guides both early and late-stage development. Understanding the market opportunity and value proposition a technology offers is key to attracting funding or finding a strategic partner. Investing millions of dollars on clinical trials can be devastating if the true commercial potential of an asset in development is not understood early in the process.
We have extensive experience and deep subject matter expertise in all core areas of the commercialization pathway, including new product planning, strategic marketing, portfolio planning, market opportunity and commercial assessments, pre-launch and launch strategy, interaction with Key Opinion Leaders, and core message development.
In addition, we can provide fund-raising preparation and high-level connections for both non-dilutive and dilutive opportunities, including:
- Investor readiness
- Access to proprietary and validated investor databases of buyers and sellers to support in-licensing and out-licensing opportunities as well as deal structure data
- Outsourced management
- Forecasting and model sizing, including review of secondary claims data, primary market research, competitive intelligence, and defining product differentiation
- Regulatory readiness for key regulatory milestones and submissions
- Harmonization of data and guidances to US FDA and global submission standards
- Access to drug sales and consensus forecasts, marketing information, and milestones
- Market intelligence for creating claims and the Ideal Package Insert
- Strategic marketing and communications planning
Proven, Unbiased, Risk Based Assessment
CSSi LifeSciences provides unbiased assessments of your intellectual property with strategic recommendations for a successful clinical and regulatory pathway to commercialization.
Our scientific and technical review of the data and the product portfolio provides unbiased portfolio assessment. We are uniquely positioned to provide a comprehensive review and “Gap Assessment” of the preclinical, nonclinical, GMP, clinical, and engineering controls to provide investors with a projected budget and timeline.
Due Diligence
CSSi LifeSciences provides in-depth technical expertise for the assessment of the likelihood of product development, regulatory and commercial success, and return on investment.
- Evaluation of preclinical and clinical development plans and strategies relative to the competitive, regulatory, and reimbursement landscape
- Evaluation of eligibility of FDA and EMA Special Designations
- Project likelihood and timing of regulatory approval and market uptake given product profile, data evidence, and product risk-benefit potential
- Evaluate product development costs and timing
Intellectual Property
CSSi LifeSciences works with companies to build an IP Fortress that conforms to your overall business strategy. In conjunction with your IP counsel, our technical experts can assist you in coordinating new IP with your regulatory and business development or partnering strategies.
