Strategic CMC Solutions for Seamless Development

From formulation design to scale-up and regulatory integration, we craft robust Chemistry, Manufacturing, and Controls (CMC) strategies that ensure your product progresses smoothly from concept to commercialization

Expertise Includes:

  • Discovery, Candidate Selection, and Developability
  • Formulation Design & Optimization for stable, scalable formulations
  • Analytical Method Development & Validation to ensure quality and compliance
  • Process Development & Scale-Up for efficient manufacturing workflows
  • Regulatory Data Preparation for FDA, EMA, and global submissions
  • Cost-Efficient Development Plans
  • Milestone-Driven Project Planning
  • Integration with In-House and External Partners
  • Interface with CMC functions, regulatory, and clinical
conceptual image showing a timeline or milestone-driven chart
Contact Us to Optimize Your CMC Strategy