Nonclinical Drug Development Consulting Services, LLC

  • Review of C,M&C sections of INDs, NDAs & ANDAs
  • Expert opinions of scale-up and validation protocols, data, and launch plans
  • SUPAC consultation & submission strategy
  • Pre-Approval readiness evaluation and preparation
  • Expert review of development pharmaceutics reports
  • Critique of analytical methods and validation packages
  • Critique of bioanalytical methods and validations
  • Optimization of dosage form design approaches
  • Analysis of product development opportunities for increased efficiency
  • Improving team effectiveness
  • Independent review of product stability and/or process robustness 

Success in today's fast-paced product development environment does not necessarily come from the result of the best research ideas, but often as a result of the speed of the development department to convert those leads into new products.  Nonclinical Drug Development Consulting Services (NDDCS) can help your organization find ways to improve product development as measured by successful product entry to the market.