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...

Cormica, a global leader in comprehensive testing services for medical devices, pharmaceuticals is proud to announce its participation in CPHI Europe 2024, held this year in Milan. Our team of experts, each with a wealth of hands-on laboratory experience, will be on-site to engage with clients and industry leaders. Meet our specialists to discuss Cormica’s extensive range of testing services and how we can support your product development and compliance needs.

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.

Cormica offers comprehensive testing services across analytical chemistry, microbiology, and physical performance validation. With expertise in GMP, GLP, and ISO17025, we ensure safety, compliance, and reliability for your products. From sterility testing to packaging integrity, we help bring life-saving innovations to global markets safely and efficiently.