CMC Consulting

Let our drug development expertise work for you whether we manufacture your product or not

Having an expert at your side not only makes you feel more confident about your project, it helps to save time and rework to get you to ultimate success more quickly. With our team of proven experts who have been down this road a number of times, we can help you navigate the barriers and complexity of regulatory requirements in pharmaceutical development. We will partner with you on individual aspects where you need assistance, or we can provide full management of the process for you. 

CMC Consulting Services

  • Project management to support or fully manage on your behalf
  • Proof of concept & pre-clinical development planning
  • Pre-formulation, formulation and product development strategies
  • Analytical method development and validation
  • Manufacturing process development and scale-up planning & validation
  • OOS and deviation investigation and resolution
  • Quality systems and supplier audits
  • Document management and control
  • Assistance with CMC documentation packages