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Quality Assurance / Engineering |
- Design of Experiment Studies (DOE)
- Change Control
- Document Control
- Process Capabilities (Cpk)
- Batch Verifications
- Stability / Kinetics
- PMA / 510K submission help
- INDA / NDA submission help
- Develop Test Methods / SOP's
- Corrective Action / Preventive Action (CAPA)
- Pre-approval Inspection (PAI) Preparation
- Resolve 483's / write-ups, and CD's
- RMA's
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Providing Quality & Validation Services for the Pharmaceutical, Medical Devices, Biotech and other industries within North America, Europe, Asia, Australia, and other areas of the world. More Details. |
Providing validation and compliance services that meet your
schedule and budget.
More Details. |
Stay current with regulations and industry demand. We create affordable deliverables and provide validation and QE services that stand up to the FDA inspections.
More Details. |
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