Cormica

Biological evaluation plans & reports (BEP & BER) Clinical evaluation plans & reports (CEP & CER) Submission support (US FDA, UK & EU MDR) Toxicological risk analysis Biological gap analysis PSUR (Periodic safety update report) Post market surveillance

Extractables & Leachables Organic & elemental impurities Leachables in condensate Particulate Emission Volatile Organic Substances (VOC & Carbonyls) Cytotoxicity Irritation Sensitisation Material mediated pyrogenicity Acute Systemic Toxicity Subacute, Subchronic & Chronic toxicity Genotoxicity Carcinogenic...

• GMP Release Testing Services • Product Characterisation • Occupational Hygiene Analysis • Purity Profiling & 5 Batch Studies • Extractables & Leachables • Material Characterisation • Stability Testing Services • Physico-chemical Properties • De-formulation

• Sterility Testing • Quality Control Release • Bioburden Testing • Method Suitability • Microbial Identification - MALDI-TOF • Bacterial Endotoxin Testing • Cytotoxicity • Environmental Monitoring • Biological Indicator Enumeration

• Combination Device Testing • Needle-based Injection System • Device Verification & Validation • Bespoke & Custom Testing • Particulate Matter Contamination • Packaging Validation & Testing • ASTM D4169 Transit Testing • ASTM F1980 Accelerated Ageing • ISO 11607 Sterile Barrier Valid...

Take a look at why Cormica is a top rated medical device and pharma testing group, see our full suite of testing services to see how we can help you.