The global capability centre model changed how companies run IT and finance. Quintalys brings it to quality and regulatory operations. Your standard, repeatable Q&R processes are run by dedicated, trained teams in cost-effective delivery locations, around the clock, with senior EU-based oversight. You get capacity, speed and consistency without building it yourself.
Talk to us about this serviceMuch of the daily work in a quality and regulatory organisation is essential, repeatable and high-volume. It ties up skilled people and slows the business when it falls behind. We take on these processes as a managed service, combining our consulting expertise with our technology solutions, so your own team can focus on decisions, design and strategy. The areas below are typical examples, not a fixed menu.
The routine running of your quality system: nonconformance and CAPA administration, change control, training records, internal audit scheduling and quality KPI reporting.
Document control and records management within your QMS: formatting, review and approval routing, periodic reviews, record retention and archiving.
Keeping regulatory information complete and current: technical documentation upkeep, labelling and IFU checks, UDI and registration data, and renewals across markets.
Complaint intake and processing, trending, vigilance tracking, literature screening and preparation of post-market reports for your review and sign-off.
Supplier files, certificates and agreements, review of acceptance and inspection records, and follow-up on supplier corrective actions.
Extra hands for remediation and audit preparation: reviewing and scrubbing historical records, closing out old backlogs, and finding and fixing gaps before an auditor does.
If a quality or regulatory task is repeatable and well defined, we can most likely run it for you. Tell us what is taking up your team's time, and we will scope it together.
We work as an extension of your quality organisation, not a black box. Process ownership and quality decisions stay with you, consistent with your obligations for controlling outsourced processes under ISO 13485. Quintalys provides the governance, the senior review and a dedicated delivery team working inside your QMS and to your procedures. A hub-and-delivery-centre structure, standard work and clear service levels make the service predictable, scalable and audit-ready.
We map the processes in scope, their volumes, systems and service levels, and agree a transition plan with you. Knowledge transfer runs alongside your team, with no disruption to day-to-day operations.
Each process is documented as standard work within your QMS, system access is set up, and the delivery team is trained on your products and procedures. A parallel-run period confirms quality before full handover.
Work moves through a follow-the-sun model across time zones, so tasks progress while your own team is offline. Agreed service levels, KPI dashboards and regular governance reviews keep performance fully transparent.
We apply Lean Six Sigma methods to remove waste and variation, automate repetitive steps, and adjust scope as your needs change. The service becomes faster and more efficient over time.
Tell us which processes are slowing your team down. We will show you what a Quintalys capability centre could take off your plate, and what it would save.
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