Practical solutions for achieving both productivity & compliance in today's confusing regulatory climate!

  • Validation design and execution (process, cleaning and analytical methods).
  • FDA Warning Letter and consent decree mitigation.
  • Protocols, SOPs.
  • Training.
  • Chemist evaluation.
  • Optimization of Laboratory efficiency and productivity.
  • cGMP audits.
  • OOS investigations.
  • Quality systems design and management.
  • Bullet-proof quality systems compliance.
  • Six Sigma applications in analytical methods and process validation.


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