VALIDATION & QUALIFICATION
An independent specialist consultancy offering high-level Validation, Quality Assurance (QA), and Regulatory Compliance services to medical device, pharmaceutical, and GxP-regulated manufacturing industries.
Delivering over 20 years of hands-on technical and leadership experience in complex site relocations, computerized system validation (CSV), advanced manufacturing NPI (e.g., metal 3D printing), and Notified Body audit readiness.
Target Markets: Startup and established medical device and pharmaceutical companies across the UK, Ireland, and the broader EU requiring expert short-term or project-based validation support.
Target Markets
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Medical device and pharmaceutical manufacturers undergoing facility expansions, cleanroom builds, or site relocations.
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Organizations preparing for stringent Notified Body audits, FDA submissions (e.g., 510(k)), or MHRA/EU GMP regulatory inspections.
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Companies scaling up New Product Introduction (NPI) lines who require dedicated Validation SMEs and QA documentation governance.