CMC Consulting

The importance of proper Chemistry and Manufacturing Controls (CMC) cannot be overstated, not just for regulatory compliance but also for patient safety. DataRevive brings nuanced understanding of CMC requirements – gained as CMC regulators themselves – to design and implement risk-based, phase-appropriate CMC solutions for the lifecycle of your drug product.

From initial development to post-approval compliance, we will help you build and execute a CMC strategy tailored to the unique characteristics of your drug product’s molecule complexity, formulation, and indication. We provide active support for:

  • IND, NDA, BLA, ANDA Strategic Guidance
  • Regulatory Dossier Writing
  • Quality Agreement and SOP Set Up
  • Quality System Establishment
  • GMP Pre-approval Inspections
  • US CDMO Search for Manufacturing
  • Process Validation Protocol Review
  • FDA Inspection 483 Remedy
  • DMF Writing
  • Coordination with Clinical Development Timelines: to support accelerated clinical development pathways
  • IND Maintenance: following manufacturing changes or for phase-appropriate comparability study design
  • Post-approval Lifecycle Management: manufacturing changes, comparability protocols, etc.

Our team includes a truly one-of-a-kind roster of former FDA CMC professionals who understand regulators’ expectations and how to navigate the continually evolving CMC landscape at a global level. No matter your product’s complexity, we will ensure quality is designed into your development and manufacturing processes from the very start, and can be maintained for as long as the drug is on the market.

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