Chemistry, Manufacturing, and Controls (CMC)

CMC is at the core of your development program

Without timely execution of your CMC product development strategy, your overall program milestones will be at risk. Rho’s CMC experts, working closely with you as part of Rho’s integrated product development team, will help you navigate through your CMC program, in all phases of development from preclinical through commercialization, and keep your program on track.

The CMC Regulatory Affairs group at Rho specializes in pharmaceutical development, regulatory strategy, and chemistry, manufacturing, and controls (CMC). Our network of regulatory professionals have extensive experience in the pharmaceutical industry and have contributed to the development of a diverse range of products, including small molecule, biologics, and gene and cell therapies.  Rho has provided input into our clients’ drug substance and drug product development plans, authored CMC related documentation for regulatory submissions, provided input on regulatory strategies related to CMC, and performed man-in-the-plant activities at contract manufacturing organizations. Further, Rho has participated in numerous FDA interactions, including pre IND meetings, End-of-Phase 2, pre-NDA/BLA, and Type A meetings. Our authors are fully-versed in electronic Common Technical Document format and have authored CMC components for a variety of submissions, including numerous pre-IND meeting packages, INDs, and marketing applications.

Our CMC services include:

  • Product development
  • Active pharmaceutical ingredient sourcing
  • Dosage form development plans
  • Gap analyses
  • CMO selection and management
  • Management of formulation development programs
  • Analytical laboratory selection and management
  • Clinical trial material
  • Review of clinical trial protocols for study supply requirements and challenges
  • Clinical trial supply management and oversight including:
    • Forecasting clinical supply needs
    • Sourcing ancillary supplies
    • Management of primary/secondary packaging, labeling, distribution, and return of clinical supplies for Phase 1 – 4 clinical trials
    • Support the development of study-specific interactive response technology (IRT) applications
    • Perform unblinded monitoring of IRT inventory at depots/sites with respect to recruitment