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We support our clients in compiling test data and preparing needed documentation in fulfilling requirements for clinical trials and/or commercialization in both the US, EU, and IC Regions.

Document Preparation:

Standard Operating Procedure, Manufacturing process instructions (SOP/MPI)

  • IQ/OQ/PQ
  • CAD (SolidWorks, AutoCAD, PRoE) generation via in house procedures

Clean Room Qualification:

APOMed provides an all-inclusive service in the qualification of clean rooms at your facility. We offer reassurance that the controlled environment is monitored to your specific requirements and applicable standards.