Our Experience
Our team brings deep, hands-on expertise across the industries we serve.
Our consultants have delivered projects across a wide range of organisations, from global manufacturers to early-stage startups. Here are some examples of the recent work our team has been involved in.
Biocompatibility Programme — Class III Implantable Device
Complete BEP, BER, and TRA programme. Coordinated testing and supported notified body review.
Cleanroom Validation — Pharmaceutical Manufacturing
Full cleanroom qualification programme including classification, environmental monitoring, and ongoing compliance.
QMS Implementation — Medical Device Startup
Built a QMS from the ground up, achieving ISO 13485 certification readiness within six months.
Validation Remediation — Global Device Manufacturer
Prioritised remediation across process validation, equipment qualification, and CSV following a regulatory inspection.
MHRA Audit Preparation — Biopharma
Readiness assessment, mock inspection, and team training ahead of an MHRA visit.