Profile
Trust, confidence and clarity are at the heart of every project we deliver. Cormica helps pharmaceutical, medical device and combination product manufacturers move forward with accurate data, dependable turnaround times and clear communication at every step. We take ownership of each project so clients feel fully supported and able to release their products with confidence.
Across our GMP, GLP and ISO 17025 accredited laboratories in the UK, US and EU, our teams work together to provide a seamless experience, combining scientific excellence with a strong commitment to doing what is right for both the product and the patient. Whether you are bringing a new concept to market or managing complex global submissions, we focus on giving you the reassurance, honesty and partnership you need.
Industries & Product Categories We Support
Cormica provides integrated testing across a wide range of regulated products, including:
- Pharmaceuticals: tablets and capsules (SODFs), modified-release formulations, generics, sterile injectables, biologics, biosimilars, lyophilised products, anaesthesia drugs, topical and transdermal medicines, ocular formulations.
- Medical Devices: catheters, infusion sets, wound dressings, dental materials, orthopaedic devices, cardiovascular devices, ophthalmic implants, surgical instruments, robotic surgery systems.
- Combination Products: pre-filled syringes, needle-based injection systems (ISO 11608), auto-injectors, on-body delivery systems, drug-eluting stents, connected or smart drug-device systems, inhalation and nasal drug products (MDI, DPI, nebulisers).
These products often face challenges in sterility, particulate control, material compatibility, extractables and leachables, device performance and global regulatory expectations. Cormica brings cross-functional expertise to solve these challenges efficiently and transparently.
Core Testing & Consultancy Services
Microbiology & Sterility Testing
Reliable microbiology is essential for patient safety. Cormica supports routine QC, sterility assurance and cleanroom environments through:
- Non-sterile Product quality control
Bioburden testing
TAMC / TYMC
Preservative Efficacy / Antimicrobial Effectiveness Testing (AET/PET)
- Sterility testing, inc Rapid sterility testing & CCIT
- Pyrogen testing
Bacterial Endotoxins Test (BET) – Limulus Amebocyte Lysate (LAL)
Monocyte Activation Test (MAT)
- Environmental monitoring and cleanroom support
- Microbial identification (including MALDI-ToF, MicroSEQ & VITEK)
- Much more inc, Reprocessing validation, Biological indicator testing, cytotoxicity testing, Disinfectant Efficacy testing, validation and batch release testing.
Analytical Chemistry & Material Characterisation
Accurate chemistry data is critical for regulatory approval and ongoing compliance. Cormica boasts over 45 validated analytical equipment and our teams provide:
- GXP Fundamentals inc : Method development, validation and transfer, QC release testing, ICH & GMP storage stability and Physico-Chemical Properties & Product Safety Registration
- Physical / Materials Characterisation inc: Particle Size, Shape, Composition & Association, Generics Support and IVBE, X-ray Diffraction and Solid State Analysis
- Chemical Characterisation inc: Organic Impurities, Residual Solvents, Elemental Impurities and Nitrosamines
- Manufacturing & Commercialisation inc: Cleaning Validation & Verification, Occupational Hygiene, Contaminants & Foreign Bodies, Extractables & Leachables, Migration, Packaging
Physical, Functional & Packaging Testing
From early verification to final validation, we support device and combination product performance with:
- Device Verification and Validation (catheters, auto-injectors, Pre-filled syringes, ONIDP, NBIS, wound care systems)
- Packaging integrity testing and CCIT
- Distribution, transit simulation and ageing studies
- Mechanical and material performance testing
Biocompatibility & Consultancy
Our consultancy and regulatory services help streamline global submissions and reduce unnecessary studies. Support includes:
- ISO 10993 strategy, BEPs/BERs and toxicological risk assessments
- Biological evaluation and gap analysis
- Regulatory pathway support for FDA, EU MDR and PMDA
Why Clients Choose Cormica
Across our network of laboratories, we focus on what matters most to manufacturers:
- Trustworthy results generated under robust quality systems
- Accurate testing and clear interpretation, reducing uncertainty
- Reliable turnaround times that protect project timelines
- Transparent, responsive communication with dedicated technical contacts
- True collaboration, shaped by our values of doing what is right, working together, and continually improving
Contact Us
To discuss testing or consultancy support, visit here or contact our team directly: sales@cormica.com