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EXPERIENCED  PHARMACEUTICAL VALIDATION SERVICES

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Validation and Qualification

  • Validation support during commissioning phase

  • Equipment Validation

  • Performance of Thermo-mapping, Validation and Qualification

  • Environmental Monitoring and Clean Room Control

  • Cleaning Validation

  • Utilities Validation

  • Shipping Validation

  • Documentation

Product Study and Regulation

  • Vendor Audits and Qualification

  • Site Audits (Mock Audits) and Regulatory Inspection Qualification

  • Stability study

    • Shelf life stability study​

    • On-going stability program

    • Statistical data and trend analysis

    • Stress study  and by-product determination

    • Stability studies under accelerated conditions

    • Development of stability indicating method

  • Gap Analysis

  • CAPA Analysis

Technology Management and Training

  • Technology Transfer

    • Technology transfer from R&D to manufacturing facility​

    • Technology transfer from one manufacturing site to another

  • Risk and Quality Risk Management

  • Basic and Specific SOP writing and Training

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+1 (866) 627-7264

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©2019 by Pharma Compliance International Pharmaceutical Validation Services.

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