Global experts in quality assurance & GxP compliance across pharmaceutical, biotech & medical device manufacturing supply chain
We are deeply experienced GxP consultants, auditors and practitioners. We’ve been proactively helping pharmaceutical and medical device companies around the world with these supply-chain quality assurance services for over 25 years.
Our GxP readiness services assess and target improvements across all manufacturing systems and processes, ensuring there are no gaps in quality or compliance, in any phases of the product development and manufacturing lifecycle.
We assess and report on a whole range of manufacturing sites and product lines, producing off-the-shelf reports available for purchase. In fact, we offer the single largest repository of live reports (within three-year validity), spanning thousands of individual products.
We are product quality experts, serving the strictly regulated life sciences industry – encompassing pharmaceutical, biotech and medical device manufacturing supply chains globally. Our services extend right across the product development lifecycle – from raw materials/device components to patient delivery.
Highlighted offerings include:-
With our honed processes, bespoke service design, appropriate use of technology, and audit report consistency, we have established an enviable reputation and are widely acknowledged to be the Gold Standard in our field.
Simply skip straight to a search to locate the reports covering the sites and products you require
Browse our global GMP audit library to see the range and scope of live reports we have in stock
Specify your own particular requirements for inclusion in an existing, upcoming inspection and report, to maximise the efficiency and cost control of your supplier auditing.
For more bespoke requirements, we perform rigorous, on-demand custom audits of pharma manufacturers across the supply chain internationally.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.