Commercialization is a process, not an event...

Planning for commercialization of your product should be part of every development program, regardless of whether your company is the one that ultimately brings the product to market.

Why? Because understanding the commercial needs and requirements of the market will drive technical development issues at various stages along the development path. This can occur sometimes, at very early stages of development. If you have planned for and incorporated these commercial considerations, it enhances the value of your overall development program.

How can Rondaxe help?

Commercial Market Assessments

• Does your drugs’ market require formulation considerations that drive the need for specialty dosage prototyping efforts or require special control of API particle size?
  
  Rondaxe can support you in your efforts to identify these type issues with a targeted market assessment. Rondaxe can then guide you or your contract suppliers through the technical development activities to address those issues.

Supply Chain Assessments

• Are your current suppliers appropriate in scale and capability to support commercial supply of your product?
  
  Rondaxe can evaluate your compound, market and suppliers and provide guidance on how to strengthen your supplier base for commercial operations and provide a plan for the development of the supply chain.

Quality Services

• Has your current supplier base been audited for GMP compliance?
  
  Rondaxe offers comprehensive GMP Audit and Remediation services to emerging pharma companies.

Product Launch Planning & Support

• Are you within two years from your projected filing and/or commercialization target?
  
  Rondaxe can support forming your launch team, building a cross functional team of development and operations representatives and integrating their activities with Clinical Operations, Marketing and Sales as you move toward your launch date.

Commercial COG Projections

• Unsure of the financial implications of your existing API synthesis or various dosage form options?
  
  Rondaxe can provide commercial COG projections for even the most preliminary API and formulation processes. We can also provide projections from Launch year sales to Peak year sales, given the appropriate supporting data. For our more hands on clients, we also offer Rondaxe’s proprietary software which has a COG Modeling functionality.