Whether you are in the early stages of managing responses to FDA 483 observations, delivering on commitments to FDA as part of a Warning Letter or Consent Decree or, you have successfully satisfied FDA and you are in the end stages of returning to a new state of normal operations, you can never go back. You must maintain your ISO 17025 compliance and Lab testing support in a state of current good manufacturing practice (cGMP) at all times.
Regulatory Compliance Associates® Inc., in partnership with Nelson Labs, can provide lab testing and consulting support:
- On-site inspections, i.e., Gap Assessment, General GMP, FDA Readiness, etc.
- Data Integrity Verification, i.e., OOS, OOT, Notebook Audit, Forensic Evaluation, etc.
- Calibration / Metrology Program Assessment
- Method Development and Validation Assessment
- Stability Study Program Assessment
- ISO 17025 Compliance Audit
- ISO 17025 Mock Inspection
- ISO 17025 Training & Development
- WFI Process Verification
- Risk Assessment for Modifications to Existing Labs or Build Out of New Labs
RCA validation testing services
Facility & Process validation
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Biological evaluation testing
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Sterilization validation testing services
Radiation validation testing
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EO validation testing
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Re-Use validation testing
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Packaging validation testing
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Additional testing services
- Sterility Assurance Testing
- QDA (Radiation)
- Product Sterility
- Verification Dosing
- Bioburden
- BET/Particulates
Sterility assurance testing
- QDA (Radiation)
- Product Sterility
- Verification Dosing
- Bioburden
- BET/Particles
- ED Lot Release
- BI Sterility
- EO Residuals
- BET/Particulates
- PCD’s
- Other Sterility Assurance
- Bioburden
- Organism ID’s
- Cytotoxicity
RCA lab compliance services
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About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
