Quality is in our DNA. We recognise that the lives and well-being of patients around the globe depend on the safe arrival of the critical healthcare products. We are committed to continually enhancing our quality excellence and have built a powerful Quality Management System that helps us do that every day.
Contact Our ExpertsWe help you navigate global compliance regulations at home and across international borders. We have relationships with more than 80 regulatory agencies, and our facilities maintain local regulatory licences in addition to ISO 13485 and ISO 9001 certifications.
Quality is an essential element of any healthcare or life sciences business. We have developed consistent and reproducible processes that we apply globally to enable effectiveness, agility, and regulatory compliance.
Our eQMS offers a single, globally integrated eQMS platform enabling advanced data-driven trend analysis reports that give you the opportunity to continually optimise and improve performance over time.
We support the efforts of our clients to provide safe and effective healthcare products to the marketplace, and utilize current validation methodology to qualify facilities and critical systems to ensure they are up to date with industry standards and best practices.
We have dedicated and independent Quality Assurance and Regulatory Affairs experts around the world with the specialised education, qualifications, and experience required for managing healthcare compliance in the countries and regions we serve.
Protect your global supply chain with a highly configurable quality management system designed to maintain the safety and efficacy of regulated healthcare products.
Schedule audits
Schedule site process inspections
Review findings
Review and approve responses
Apply scoring
Record CAPAs
Capture preventive actions
Assess risk and impact breadth Track action plans Verify effectiveness
Assess risk
Assess impact
Develop action plans
Obtain approvals
Record non-conformances
Manage market actions/recalls
Review investigations
Track action plans Identify trends
Manage controlled documents
Review and approve documents
Approve appropriate variances
Assign training
Evaluate training effectiveness
Monitor training status
Identify trends
Our approach to quality management is simple, we hold our systems, processes and procedures to the highest standard to ensure the safe arrival of healthcare products around the world.
We use our electronic QMS, which helps protect your global supply chain with a highly configurable design to maintain the safety and efficacy of regulated healthcare products.
Yes. Complying with ever-changing requirements continues to be a top concern for healthcare. Since we operate in over 220 countries, our logistics teams are made up of experts with strong local relationships and we can provide services to help you manage your overseas business.
At our Parcel Testing Lab, we can test the sensitivity of packaging and the effects of extreme temperatures and humidity, so we know how packaging will perform in various conditions and adjust packaging strategy accordingly.
Our specialised air and ocean freight containers help keep your products within specified temperature ranges throughout the transportation cycle.
And with our global footprint of more than 70 facilities housing a full range of temperature-controlled environments, you can trust your products are in good hands.
Our facilities maintain local regulatory licences in addition to ISO 13485 and ISO 9001 certifications, across a global network of more than 17.2 million square feet (1.5 million square metres) of warehouse space.