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Quality/Regulatory Compliance

Post approval changes

  • Impact analysis and study design for DMF updates, Compendia updates, method improvement, alternate API qualification, line extension

Technology transfer

  • Study and report design

Implementation or improvement of quality/regulatory compliance

Auditing and preparation for GMP inspection

Troubleshooting and problem solving for method or product related vvvvissues, stability and OOS results

 

 

Consulting Services

Analytical Research and Development

Quality/Regulatory Compliance

Teaching, Training and Coaching

 

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