CMC Regulatory Support

We can guide and assist in the CMC development including:

  • CMC Strategies for Analytical Development, Drug Substances, and Drug Product Manufacturing
  • Preparation of CMC regulatory submissions to US and International Agencies 
  • Technical and Regulatory-Project Planning
  • Technology Transfer and Process Validation
  • Analytical Transfer and Validation
  • Risk Based Approach for Development of Biologics and Biosimilars
  • Stability Programs for Drug Substances and Drug Products


We have the senior quality management experience to create effective quality systems and provide interim quality leadership. 

  • CMO Selection, qualification, and monitoring via due diligence, qualification audits, quality agreements.
  • Facility Design and Validation 
  • Validation Master Plan Development
  • Setting up and Monitoring Quality Systems in Compliance with cGxP Regulations
  • Personnel Training
  • Mock Pre-approval Inspections