CONSULTING

Rondaxe CMC consulting group is focused on providing drug development and manufacturing strategies to the pharmaceutical industry, concentrating on providing services to emerging and specialty pharma companies. Rondaxe employs a diverse group of former directors and senior managers from the pharmaceutical industry with expertise with chemical, fermentation, drug product and analytical development, supply chain strategy, manufacturing operations, quality control, quality assurance and regulatory affairs.

  • CMC Consulting Services
  • Chemical Development
  • Drug Product Development
  • Manufacturing Cost of Goods Analysis
  • Quality Assurance
  • Process Research & Development
  • Analytical
  • Supply Chain & Manufacturing Strategy
  • Fermentation & Biocatalysis Development
  • Regulatory Affairs

Since our founding in 2003, Rondaxe has worked with many different types of companies:

  • Emerging pharmaceutical and biotechnology companies
  • Medium size pharmaceutical companies
  • Large/established pharmaceutical companies
  • Contract research, development and manufacturing organizations
  • Venture and private capital investors

Analytical

Our analytical development team has comprehensive methods development and validation experience.

Services

  • Analytical strategy development
  • Analytical testing/validation strategy
  • IPC & PAT method development
  • Drug product analytical methods development
  • Report documentation

Benefits

  • Stage appropriate analytical strategies
  • Access to our highly experienced industry team