CMC Consulting

Our veteran team has the knowledge and expertise necessary to guide you through the development process.

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

  • CMC Project Management and Planning
    • CMC Project Management Team
    • Formulation
    • Analytical
    • Manufacturing
    • Process Development
    • Scale-up
  • Analysis and Selection of CDMO’s and CRO’s
  • Develop Network of Drug Development and Manufacturing Suppliers and CRO’s
  • Authoring and Reviewing CMC Regulatory Filings (IND’s, NDA’s, FDA queries, supplements and amendments, annual reports, site inspections observations, 483’s and warning letters)
  • Product Development
    • Product development strategy
    • Participate as members of the product development team
  • Process Design, Validation and Troubleshooting
    • OOS and OOT investigations
    • Stability programs and failures
    • Sterility failures
    • Validation of processes, methods and equipment
  • Compliance with cGMP Requirements
  • Drug Product Instructions
    • Dosage preparation instructions
  • Technical Business Support
    • Support due diligence efforts of investors, licensees, buyers, M&A activities
    • Assist with preparation of presentations