Diagnostics

We understand the pressures that clinical diagnostic companies face when acquiring, developing and introducing products or technologies – and in financing sustainable growth in a market with constantly emerging new products and competition.  It is expensive and risky to introduce new technologies and products. Customers, regulators and payors do not approve, use or pay for products without proof of benefit … frequently economic as well as medical.   Biomarker discoveries are rapidly evolving. The clock is ticking, and every decision can be costly.

To ensure you don’t waste money on poor or marginal opportunities, you should always start with an opportunity assessment. A well-designed opportunity assessment will help you optimize your regulatory, marketing, sales, and business strategy before spending even one extra dollar, Euro, pound, or yen.  We have the technical insights and commercialization experience to help manage the regulatory and legal processes and make you successful in the global market.

We can help you with:

• Technology Assessment and Valuation
• Opportunity Assessment & Key Opinion Leader Research
• US Product Launch Strategy & Implementation
• Distribution Agreements, Partnerships & Acquisitions
• US Subsidiaries for European & Asian Companies
• Management of Regulatory Affairs, Patent Actions & Reimbursement

"Commercialization is all part of brand management, how you build a brand. The companies who specialize in this may prove very helpful" says Dr. Robert Keefer. Read Companies Supporting Other Companies from The State of Life Sciences in North Carolina (Supplement) in The Scientist. To view the full article, click on The Scientist, April 2007.

Getting FDA approval is the first crucial step in bringing a product to market. But negotiating reimbursement with the payers should have the same priority. This TCG White paper discusses the Do’s and Don’ts.