Complete CMC Consulting

Chemistry

  • Process suitability and scalability
  • Predicting bottlenecks at scale
  • Bridging the gap between Q11 and your process
  • Critical process parameters
  • Impurities and degradation
  • Stability

Manufacturing

  • Scale-up and process adaptation
  • Process validation
  • Reaction and process safety
  • OEL classification
  • Cost competitiveness
  • Avenues for cost reduction

Controls

  • Compliance to Q7
  • Devising specifications for Input, in-process and Output
  • Cost controls
  • Validations of Analytical methods

Documentation

  • MBR
  • BMR
  • Process development report
  • Standard testing procedures
  • Product development report
  • DMF compilation
  • CMC section compilation