Rozamus and Associates offers pharmaceutical consulting services for both strategic guidance and operational execution for every aspect of CMC (Chemical Manufacturing and Controls) development for potential therapeutic agents, consistent with current regulatory requirements.  Our team of pharmaceutical professionals is well positioned to provide guidance, based direct experience in navigating all phases of the product life-cycle, from pre-clinical through approved commercial products.

  • Development of cost efficient and phase appropriate CMC regulatory strategies.
    • Generation of a product development plan detailing specific milestones
    • Product life-cycle management in line with current FDA/EMA expectations and industry best practices
    • Coordination of phase appropriate activities to reduce the risk that CMC requirements are critical path or rate-limiting during clinical development
  • Incorporation of Quality by Design (QbD) and Quality Risk Management (QRM) principles into effective control strategies.
    • Development of a Quality Target Product Profile and Critical Quality Attributes 
    • Identification of key quality risk factors and mitigation 
    • Application of Design of Experiment (DoE) process R&D studies to provide statistically rigorous process control justifications
    • Organization and presentation of data to provide the optimal regulatory flexibilities and commercial opportunities
  • Chemical development from process design to validation
    • Execution of required product characterization studies through 3rd party contract laboratories
    • Synthetic route evaluation and selection
    • Raw materials sourcing and procurement
    • Optimization of process operations and controls
    • Authorship or editorial responsibilities for development reports and related CMC regulatory filings
  • Management of outsourced (3rd party) contract manufacturing for active ingredients (API) and formulated drug products
    • Identification of qualified vendors and cGMP contract manufacturers (CMO)
    • Cost-effective CMO selection through and competitive proposal process
    • Technology transfers management
    • Identification of appropriate analytical methodologies
    • On-going manufacturing oversight, including process qualification studies to support commercial manufacturing