Symbio’s strategic consulting and product development services include support for your IND, NDA, ANDA or medical device application. Even before the decision is made to pursue a new product, Symbio can help with project plans and development scenarios to determine feasibility. Each program has unique requirements and parameters. Symbio configures consulting services to best accommodate each specific program’s needs. A consulting arrangement with Symbio can be established by project, by hour or on a retainer basis. Symbio works with a number of firms and individuals that contribute specialized expertise to development programs.

Typical consulting services:

  • Project planning and product development strategy
  • Research of clinical development plans
  • Design of clinical development plans
  • Review of patents and patent strategy
  • Formulation performance assessment (in vitro and in vivo)
  • Project management (on going) and problem solving (as needed)
  • Preparation of IND, NDA, ANDA & medical device submissions
  • Protocol development
  • FDA correspondence (meeting preparation and briefing packages)

 

 

 

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21 Perry Street • Port Jefferson, NY 11777 • (631) 474-8531
Email: rpanico@symbioresearch.com