Chemistry Manufacturing and Controls (CMC) Consulting Services


Our experts provide regulatory guidance in:

  • Setting specifications
  • Method selection/development
  • Process and method validation
  • Stability studies.

We identify contract manufacturers and arrange contract laboratory services.

We can conduct GMP audits and provide supporting consulting services

Our CMC team has extensive experience with small molecule development, dosage forms, routes of administration and therapeutic areas.

We have advanced degrees in a variety of scientific and business disciplines and work experience in large pharmaceutical organizations and virtual/start-up operations.

CMC Regulatory Services:

  • Preparation and review of regulatory submissions, including:
  • Investigational new drug (IND)
  • New drug application (NDA)
  • Abbreviated new drug application (ANDA)
  • Authoring of annual reports, drug master files, dossier amendments and supplements
  • Preparation of electronic common technical documents (eCTD) applications

Active Pharmaceutical Ingredients and Clinical Trial Material Sourcing and Management:

  • Scientific/project-specific site visits
  • GMP audits to evaluate vendor staff and facility capabilities necessary to execute your program
  • Interpretation of scientific results
  • Advice on setting appropriate specifications, assigning product shelf life and conducting failure investigations
  • Project management services