- Complete document packages with continued Regulatory Support
- CMC regulatory support for your IND
- Mature quality system with dedicated QA/QC and Regulatory Team
- Master Control 21 CFR Part 11 Compliant Quality System Management using Master Control™:
- Validated system for document and change controls
- CAPA
- Training
- Audits
- Complaints
- Validations
- Materials Management System:
- Quarantine
- Storage
- Shipping
- Regulatory compliance under:
- ISO 9001
- Quality System Regulations
- Applicable sections of 21 CFR 820
- Current Good Manufacturing Practices
- Applicable Sections of 21 CFR 210, 211
- USDA Regulations
- Applicable sections of 9 CFR
- EC1069/2009
- Export Administration Regulations (EAR)
- DOT/IATA Regulations
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Meridian Life Science offers a range of in-house testing services for characterization of custom R&D and contract clinical cGMP biologic materials. Our capabilities include:
- Assay development and validation
- Customization and standardized test procedures
- Viral quantitation and infectivity assays
- Validated in-house Biopharmaceutical Assays for release of biopharmaceutical products:
- Sterility (USP)
- Bacteriostasis and Fungistasis (USP)
- BCA Protein Concentration
- pH, appearance, osmolality
- Intact Cell Assay
- Residual Benzonase
- Endotoxin (USP)
- Custom Assays developed/validated as needed
- 3rd party GMP and GLP Testing Services:
Meridian Life Science uses qualified and audited 3rd party providers for clinical cGMP characterization of clinical biopharmaceutical products
- In-house Testing and Custom Assay Development:
Meridian Life Science can assist you in development of custom assays and can conduct most standard test methods:
- Purity by Western Blot or Silver Stain PAGE
- Total Protein (BCA)
- Isoenzyme Analysis
- HPLC Profiling
- ELISA (direct or capture)
- Others as appropriate
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