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 

• 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