Cormica
Cormica® Ltd
Cormica offers comprehensive biocompatibility testing services for medical devices, ensuring safety and compliance with ISO 10993 standards. Accelerate your product development with expert guidance and reliable data.
Cormica provides expert biocompatibility testing services for medical devices and combination products, ensuring they meet stringent ISO 10993 standards and global regulatory requirements. With decades of experience and GMP, GLP, and ISO 17025 accredited laboratories across the UK, EU, and US, Cormica supports manufacturers from R&D through to post-market surveillance. Their services include developing Biological Evaluation Plans (BEPs) and Reports (BERs), and navigating complex regulations like EU MDR and FDA guidance. Cormica's team offers clear guidance, dependable timelines, and data you can rely on, helping you move products forward with confidence. They specialize in assessing interactions with biological systems to ensure product safety for human use, offering a comprehensive suite of tests tailored to your device's intended use and contact duration. Leveraging a scientist-to-scientist approach, Cormica ensures reliable and reproducible results, accelerating your path to market. They are committed to improving patient lives by enabling safe and timely product launches through comprehensive and reliable testing solutions.
About
**Who they are**
Cormica is a specialist contract research organization (CRO) with over 30 years of analytical experience, providing comprehensive testing services for pharmaceutical and medical device manufacturers. They operate GMP, GLP, and ISO 17025 accredited laboratories across the UK, US, and EU.
**Expertise & scope**
* **Biocompatibility Testing:** Comprehensive ISO 10993 testing services to evaluate medical device interaction with biological systems, ensuring safety and regulatory compliance. This includes guidance on test selection based on product use and contact duration.
* **Analytical Chemistry:** Phase-appropriate method development, validation, QC release testing, and stability studies for APIs, pharmaceuticals, and medical devices. Expertise covers residual solvents, particle size, assay, polymorphic form, and more.
* **Method Development, Validation & Transfer:** Developing and validating efficient, accurate, and robust analytical methods tailored to specific product needs and regulatory requirements across various sectors.
* **Generic Pharmaceutical Development:** Supporting ANDA submissions with analytical solutions for Q1/Q2/Q3 equivalence studies, in vitro bioequivalence studies, and impurity identification/synthesis.
* **Particle & Powder Characterisation:** Detailed analysis of particle size, morphology, surface area, and bulk properties for solid and suspension dosage forms, including nanometre to millimetre ranges.
* **Extractables and Leachables (E&L):** Comprehensive testing to support biocompatibility risk assessments for drug products, medical devices, and packaging, simulating clinical use and exaggerated conditions.
**Reputation / proof points**
* Operates GMP, GLP, and ISO 17025 accredited laboratories.
* Over 30 years of analytical experience.
* Laboratories located in the UK, US, and EU.
Cormica is a specialist contract research organization (CRO) with over 30 years of analytical experience, providing comprehensive testing services for pharmaceutical and medical device manufacturers. They operate GMP, GLP, and ISO 17025 accredited laboratories across the UK, US, and EU.
**Expertise & scope**
* **Biocompatibility Testing:** Comprehensive ISO 10993 testing services to evaluate medical device interaction with biological systems, ensuring safety and regulatory compliance. This includes guidance on test selection based on product use and contact duration.
* **Analytical Chemistry:** Phase-appropriate method development, validation, QC release testing, and stability studies for APIs, pharmaceuticals, and medical devices. Expertise covers residual solvents, particle size, assay, polymorphic form, and more.
* **Method Development, Validation & Transfer:** Developing and validating efficient, accurate, and robust analytical methods tailored to specific product needs and regulatory requirements across various sectors.
* **Generic Pharmaceutical Development:** Supporting ANDA submissions with analytical solutions for Q1/Q2/Q3 equivalence studies, in vitro bioequivalence studies, and impurity identification/synthesis.
* **Particle & Powder Characterisation:** Detailed analysis of particle size, morphology, surface area, and bulk properties for solid and suspension dosage forms, including nanometre to millimetre ranges.
* **Extractables and Leachables (E&L):** Comprehensive testing to support biocompatibility risk assessments for drug products, medical devices, and packaging, simulating clinical use and exaggerated conditions.
**Reputation / proof points**
* Operates GMP, GLP, and ISO 17025 accredited laboratories.
* Over 30 years of analytical experience.
* Laboratories located in the UK, US, and EU.
Additional information
Cormica emphasizes a scientist-to-scientist approach, allowing direct collaboration with their laboratory teams for bespoke method development or verification of existing methods. Their integrated approach supports the entire product lifecycle, from early development through to post-market surveillance. They offer flexible capacity and rapid turnaround times, aiming to accelerate product development and market entry with reliable data and expert guidance. Buyers should consider their global laboratory network when planning multi-region submissions or requiring localized testing support.
Key Highlights
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Offers comprehensive ISO 10993 biocompatibility testing services for medical devices.
Source
“Cormica provides comprehensive ISO 10993 testing services, offering expert guidance to help you navigate the complex requirements of medical device testing.”
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Provides Extractables and Leachables (E&L) testing as part of biocompatibility risk assessment.
Source
“As part of Biocompatibility risk assessment of a medical device, typically Extractables and Leachables levels are assessed.”
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Specializes in analytical chemistry method development, validation, and transfer for pharmaceuticals and medical devices.
Source
“Cormica is a specialist CRO focused on problem solving and delivering high quality analytical and laboratory support.”
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Supports generic pharmaceutical development with analytical solutions for ANDA submissions.
Source
“Cormica provides an unrivaled breadth of analytical solutions, techniques and applications to the pharmaceuticals, medical devices, healthcare, agrochemicals, biocides, food and feed sectors, including pesticides.”
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Conducts detailed particle and powder characterisation for solid and suspension dosage forms.
Source
“A detailed understanding of particle and powder properties is key to the successful development of solid and suspension dosage forms, from tablets and capsules to inhalation and nasal spray products.”
Certifications & Trust Signals
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Operates GMP, GLP, and ISO 17025 accredited laboratories.
Source
“We pride ourselves on providing comprehensive product testing services through GMP, GLP, and ISO 17025 accredited laboratories across the UK, EU, and US.”
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Has over 30 years of analytical experience.
Source
“Backed by over 30 years of analytical experience, our scientists work as an extension of your team to ensure the highest standards of accuracy, reliability, and regulatory compliance.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking ISO 10993 biocompatibility testing.
- Pharmaceutical companies developing generic or complex generic drugs.
- Companies requiring specialized analytical chemistry services for product development and QC.
How engagement typically works
- Direct collaboration with scientific teams.
- Project-based or ongoing analytical support.
- Consultative approach to method development and validation.
Typical deliverables
- ISO 10993 testing reports.
- Validated analytical methods.
- Extractables and Leachables study reports.
- Particle and powder characterisation data.
- ANDA submission support data.
Good to know
- Best when requiring accredited laboratory services (GMP, GLP, ISO 17025).
- Ideal for projects needing expert guidance on complex regulatory pathways.
- Suitable for companies with global product development and regulatory needs.
HQ:
London, UK
Languages:
English
Timezones:
UTC, GMT, BST
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, United Kingdom, Japan, South Korea, Asia
Industries:
Medical Devices
Iso10993 Standards Supported:
ISO 10993-1
Test Types Offered:
Genotoxicity, Systemic toxicity, Biodegradation, Other
Is Accredited:
Yes
Glp Compliant:
Yes
Has In House Toxicology:
No
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Regions Served:
UK, EU, US
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, EN ISO 10993-1, ISO 18562-1
Test Types Offered
Biocompatibility testing, Genotoxicity, Local Effects After Tissue Contact, Extractables and Leachables, Particle / Powder Properties & Characterisation, Analytical Chemistry Testing, Microbiological Quality Control Testing, Sterility Testing, Environmental Monitoring, Bacterial Endotoxin Testing, Method Development, Validation & Transfer, Generic Pharmaceutical Development
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks
Quote SLA
24-48 hours
Pricing Model
Per project
