Quality and Regulatory Compliance
Quality is built into every product we supply and every project we deliver, guided by global GMP standards and a documented quality management system.
Global Standards Our Network Meets
We work with manufacturing and laboratory partners certified to internationally recognised quality frameworks.
Six Pillars of Our Quality System
Our QMS covers the full lifecycle, from vendor approval to post market surveillance, so every batch is traceable and every decision is documented.
Regulatory ServicesVendor Qualification
Site audits and approval before any partnership.
Testing and Release
Raw material, in process and finished product testing.
Documentation
GMP compliant batch records and SOPs.
Change Control
Controlled, assessed and approved changes only.
Deviation and CAPA
Root cause analysis and corrective actions.
Stability Monitoring
Ongoing stability programmes for marketed products.
Inspection Ready Every Time
Gap Assessment
Detailed review against target GMP guidelines.
Remediation
CAPA plans, SOP updates and team training.
Mock Audit
Realistic inspection simulation by senior auditors.
Inspection Support
On site support during the regulatory inspection.
Preparing for a GMP Inspection or Registration?
Share your requirement and our specialists will get back within one business day with a clear plan, timeline and quote.