Our Solutions

For us, working with our clients is about serving as trusted partners, fostering connections, and bridging gaps with a commitment to transforming decisions into actions and delivering lasting results.

 

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  • Aseptic Processing & Environmental Monitoring

    • Development of cleanroom environmental and personnel monitoring programs.

    • Support trending for cleanrooms and utilities.

    • Aseptic fill-finish monitoring and media fill qualification.

    • Development of critical utility monitoring and testing programs: compressed air, gases, water systems.

    Microbial Testing and Analysis

    • Microbiological assay validation (Sterility Testing, Bioburden Testing and Endotoxin Testing).

    • Development Microbial Risk Assessment.

  • Contamination Control Strategy (CCS) Development

    • Development and implementation of site-wide contamination control strategy (CCS)

    Contamination Investigation and Remediation

    • Define problem statement, root-cause analysis, corrective/preventative action plan development and implementation, effectiveness verification and Closure

  • Project Initiation, Planning, Execution, Monitor & Controlling and Closing

    Continuous improvement programs (6S, visual management e.t.c)

  • Environmental Monitoring

    Utilities Testing

    Contamination Control (CCS)

    Microbiology Laboratory Management

Learn about our Solutions

Our Engagement Process

A structured approach to delivering measurable results and sustainable compliance

1
Discovery & Assessment

Comprehensive analysis of your current state and regulatory requirements to identify gaps and opportunities.

2
Strategy Development

Tailored approach with clear deliverables, timeline, and measurable success criteria for your specific context.

3
Implementation

Hands-on execution working alongside your team to ensure practical application and knowledge transfer.

4
Sustainable Outcome

Training, documentation, and systems for long-term success and continuous compliance beyond our engagement.