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Biotechnology Industry Consulting

We offer Consulting Services in the areas of Regulatory affairs, Quality Control and assurance and CGXP Compliance 

  • IND, NDA and BLA FDA and EMEA submission strategic planning and review
  • Project portfolio evaluation and evaluation of Clinical and  Regulatory implications and strategy 
  •  Validation of Processes and Analytical Methods including Risk Management approaches and documents 
  • Evaluation of Corporate Quality Systems
  • QC specification analysis and evaluations
  • Stability study design and program evaluations
  • Product expiration dating analysis
  • Design of Shipping and handling studies
  • Risk assessments
  • cGXP Compliance activities and strategic approaches 

Device Development

  • Drug Device combination feasability and regulatory pathway stategic planning
  • Device Regulatory filing expertise
  • Autocad Device design
  • Prototype development in plastic, Al, Steel or rare metals
  • CNC production G-code development
  • Assistance in evaluating cGXP device manufacturers
  • Prototype to production strategic planning


Construction plans