Services

•  Subject Matter Expert Trainings

– GMP

– Particles in Solution

– Technical writing

– Manufacturing Bio-pharmaceuticals               

•  Audits

– Quality System Processes:

• Third party independent review

• Investigations 

  (Non-conformance/Deviation, Complaints)

• Investigation presentations

• CAPAs

• Validation reports

– Regulatory inspection readiness

• Stress-test investigation owners

– Conduct audits or technical visits to suppliers

•  Quality System Processes

– Development of Programs and Procedures

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