Our commitment to quality

Quality is the foundation of our operations. We take a disciplined, methodical approach to every process, ensuring each step — from API development through manufacturing — meets the highest standards of consistency, traceability and control.

Our Quality Management System (QMS) combines structured oversight with a culture of accountability, enabling teams to collaborate while maintaining full compliance with FDA expectations and global GMP guidelines.

Our quality capabilities

Backed by quality systems designed to maintain consistency and control across every stage of your project, each element of our QMS is built to meet the highest regulatory expectations.

• SOP lifecycle management built on cGMP principles and full 21 CFR compliance.
• 21 CFR Part 11-compliant data systems supporting data integrity and traceability.
• Regular internal audits and self-inspections.
• QC and manufacturing systems are routinely inspected by the FDA and DEA.
• DEA registration as an analytical laboratory (no observations in 2025 inspection).

Strengthening our quality ecosystem

As part of our expansion, we aim to modernize our quality infrastructure, implementing validated electronic systems to strengthen data integrity and streamline quality processes, including:

• Electronic QMS for SOP control, deviations, CAPAs, change management and risk assessments
• Document management system for controlled documents, including batch records, protocols, and forms
• Training management system for automated training assignments, tracking, and compliance certification
• Laboratory information management system to enhance data integrity, sample tracking and analytical reporting in QC labs.

Developed in line with FDA and international Annex 11 standards, these systems give you the assurance of secure, transparent and compliant operations.