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Chemistry Tests: * Arsenic * Elemental Analysis * Gravimetric Analysis * Acid Digestion * Organic Volatile Impurities * Hyaluronic Acid * Phenol Formaldehyde Resin * Polystyrene Standards * Dextrose * Methyl Cellulose * Cellulose Acetate * Adsorbable Organic Halogens * Alcohols * Alkalinity * Aluminum Chloride Assay * Other monographs and new test methods
Microbiological Tests: * Sterility * Microbial Identification * Bioburden * Disinfectant Efficacy * Enrichment * Temperature Mapping * Environmental Monitoring * Bacterial Endotoxin * Turbidity * Preservative Challenge Test * Limulus Amoebacyte Lysate
Validation: Our services in this area include development, review, execution, and approval of master plans, protocols, and summary reports. We provide comprehensive and high quality services in the following areas:
* Computer Software * Computer Hardware * Manufacturing Process * Test Method * Autoclave * Refrigerator * Freezer * Lab Equipment * Cold Chain * Cleanroom * Aseptic Process * In-Situ Efficacy Evaluation of Disinfectants * Incubator.
Auditing: Each experienced GXP Auditor in our organization conducts an average of forty audits each year in both medical device and pharmaceutical industries worldwide. Regulation and Standards covered include:
* GCP * GLP * GMP * ISO 9001:2000 * ISO13485:2003 * Canadian Regulation (CMDR) and * MDD * AIMDD * IVDD
Consent Decree Management: We provide cost effective solutions in handling statement of work under consent decree.
Training: We provide GXP training with certificates of training recognized by industry third-party auditors. Our training programs include:
* GXP Overview * Auditing Techniques and Guidelines * CAPA Implementations * OOS Investigations and Root-Cause Analysis * Design Control * Good Laboratory Practices * Good Clinical Practices * Good Documentation Practices * Aseptic processing * Validation * ISO Registration Process * Supplier Quality Implementation and Management. * Quality Systems Architecture
8025 Lamon Avenue
Skokie, IL 60077 US