Cormica Ltd

Cormica Ltd is a specialist contract testing organisation with over six decades of heritage, delivering end-to-end analytical, microbiological, and physical testing solutions to pharmaceutical, medical device, and combination product manufacturers worldwide. Headquartered in London, United Kingdom, with accredited laboratories in the UK, EU, and United States (including Focus Laboratories in Allentown, Pennsylvania), Cormica supports clients at every stage of the product lifecycle—from early-stage R&D and formulation development through to quality control release, stability programmes, and post-market surveillance. The organisation's GMP-, GLP-, and ISO 17025-accredited facilities operate under UKAS accreditation and in compliance with FDA, MHRA, and EU Medical Device Regulation (MDR) requirements, providing a regulatory framework that gives manufacturers confidence in data underpinning critical product and process decisions.

Cormica's microbiology division provides a comprehensive portfolio of quality control testing for non-sterile and sterile products. Services include total aerobic microbial count (TAMC) and total yeast and mould count (TYMC) enumeration to USP <61> and Ph. Eur. 2.6.12; specified microorganism detection (absence testing for E. coli, Pseudomonas aeruginosa, Salmonella spp., and Staphylococcus aureus) per USP <62> and Ph. Eur. 2.6.13; and pre-sterilisation bioburden determination per ISO 11737-1. The team also delivers preservative efficacy testing (antimicrobial effectiveness testing, AET/PET) following USP <51> and Ph. Eur. 5.1.3, method suitability and pharmacopoeial validation, potable and purified water microbiological monitoring per USP <1231> and EU GMP Chapter 7, growth promotion testing (media suitability) aligned with USP <61>, <62>, <71>, and Ph. Eur. 2.6.1, and quantitative environmental swab enumeration supporting facility hygiene programmes in line with ISO 14644 and EU GMP Annex 1.

The analytical chemistry team provides extensive impurity analysis covering all regulated impurity classes across the full product lifecycle. Organic impurities from excipients, degradants, process residues, and contaminants are characterised using HPLC with tailored detection. Nitrosamine risk assessment and ultra-sensitive screening is conducted via targeted LC-MS and GC-MS to achieve regulatory detection limits for this carcinogenic impurity class. Residual solvent testing uses validated USP <467> headspace GC-FID methodology covering all ICH Q3C solvent classes. Extractables and leachables (E&L) studies are delivered in alignment with ISO 10993 and USP <1663>/<1664>, supporting biocompatibility risk assessments for medical devices, wound care products, and drug delivery systems. Elemental and inorganic impurities are quantified by ICP-MS and ICP-OES per ICH Q3D and USP <232>/<233>, with classical methods such as residue on ignition and sulphated ash also available. Water content is determined via loss on drying, thermogravimetric analysis (TGA), and Karl Fischer titration (volumetric, coulometric, and oven methods) from ppm to 100% levels. Polymorphic impurity profiling uses X-ray powder diffraction (XRPD) and differential scanning calorimetry (DSC). Particulate matter testing for parenteral and ophthalmic preparations is conducted to USP <788> via light obscuration and morphological particle identification.

Cormica's physical and packaging testing services assess the mechanical integrity and container-closure performance of medical devices and pharmaceutical packaging systems. Physical and mechanical testing follows standards including ISO 11608, ISO 11040, and ISO 80369. Packaging validation programmes are conducted per ISO 11607-1, encompassing seal integrity, container-closure integrity testing (CCIT), accelerated and real-time ageing, and transit and distribution simulation. The organisation also performs specialist device-level work including cardiovascular device fatigue and durability testing, pre-filled syringe testing, intraocular lens (IOL) evaluation, and orthopaedic implant and wear testing—reflecting deep expertise in highly regulated Class II and Class III medical device categories.

Underpinning all analytical work is a state-of-the-art instrumentation suite validated to GMP and GLP standards. Equipment includes HPLC and UPLC systems with multiple detectors, GC-FID, GC-MS, and GC-QQQ platforms, triple-quadrupole LC-MS (LC-QQQ), ICP-OES and ICP-MS for trace elemental analysis, volumetric and coulometric Karl Fischer titrators with oven attachment, XRPD, DSC, and light obscuration instruments with morphological particle identification. This breadth of instrumentation enables high-sensitivity detection, quantitation, and characterisation of all major impurity classes from trace levels through to high-concentration determinations, supporting both phase-appropriate method development and fully validated routine release methods.

As a CDMO support partner, Cormica integrates into client development programmes through phase-appropriate method development, analytical method validation, and routine QC testing for stability studies under ICH-aligned conditions. Regulatory expertise spans ICH Q3A/B, Q3C, Q3D, ISO 10993, Ph. Eur., and USP frameworks, enabling clients to compile dossiers satisfying expectations of the FDA, EMA, MHRA, and global health authorities. Clients include top-tier pharmaceutical companies, leading medical device OEMs, and combination product innovators across Europe, North America, and Asia, with testimonials from Gerresheimer Bünde GmbH, Prosys International Ltd, KIMAL, Cantor and Nissel, and a Top 5 Pharmaceutical Company in India attesting to Cormica's professionalism, technical accuracy, and project ownership throughout complex, time-critical programmes.