Expert Compliance & Quality Consultancy for Medical Device, Pharmaceutical and Biopharma Industries
Biocompatibility Assessment, Validation, Cleanroom Design and Testing, Regulatory Compliance, and Quality Management Systems (QMS) — delivered by senior consultants with decades of hands-on industry experience.
Talk to UsWhat We Do
Services at a Glance
We support organisations in regulated manufacturing and life sciences to achieve and maintain compliance across the full product lifecycle.
Biocompatibility Assessment
BEP, BER, and Toxicological Risk Assessment to ISO 10993. ERT-Certified Toxicologists.
02Validation Services
IQ/OQ/PQ, Sterilisation (EtO/ Gamma/ Moist Heat), Process Validation, Equipment Qualification, Cleanroom Validation, and Computer Systems Validation (CSV). ISO 13485, GHTF, FDA CFR.
03Cleanroom Design & Testing
Classification, Design, Environmental Monitoring, and Compliance Testing to ISO 14644.
04Regulatory Compliance
ISO 13485, FDA 21 CFR Part 820, EU MDR, IVDR, and MHRA.
05Quality Management Systems
QMS Implementation and Improvement across ISO 9001, ISO 13485, ISO 14001 & ISO 45001.
06Auditing & Training
Audit Preparation, Mock Inspections, and Regulatory Training Programmes.
About DXR
Who We Are
DXR Consulting is a specialist consultancy supporting the medical device, pharmaceutical, and biopharmaceutical industries with hands-on regulatory, quality, and validation expertise. Our team has spent their careers working in-house at organisations of every size, and that perspective shapes everything we do.
Why DXR?
In-House Experience
Our consultants have worked inside organisations of every size, from global manufacturers to early-stage startups. We understand your challenges because we've been there ourselves.
Fast & Flexible
You'll work directly with senior consultants who can get started quickly and adapt to your timelines. No layers, no delays.
Depth You Can Trust
With 10–30+ years of individual experience and registered toxicologists on the team, you're in safe hands.
Our consultants have delivered biocompatibility programmes, validation projects, cleanroom qualifications, and QMS implementations for organisations ranging from global manufacturers to early-stage startups.