Aseptic Sterility Assurance
& Troubleshooting
Ensure the highest standards of sterility and safety in your pharmaceutical products with our Aseptic Sterility Assurance services
Aseptic Sterility Assurance
Our team experts, recognized industry-wide, will collaborate with you to develop, validate, and maintain compliant processing & QA measures that prevent contamination & ensure product integrity.
Your sterile products will meet FDA, EMA, and global requirements.
Our experts will cover:
- Facility, Equipment and Utility design, use and control
- Aseptic & sterilisation techniques, isolators & RABS
- Process design, development and validation
- Enviromental & Process control
- Product inspection
- Filtration Cleaning and disinfection
- Personnel activities & behaviour
Troubleshooting Quality Issues
Resolve critical quality issues promptly with Galenisys’ Troubleshooting Quality Issues service. Our experts employ our methodology to identify root causes of quality problems and implement effective solutions.
We provide rapid, targeted interventions to mitigate risks and ensure your products meet the regulatory standards of safety and efficacy.
Our experienced team will help you navigate and resolve complex quality challenges, minimizing downtime and maintaining product integrity.
