Innovating

In the pharmaceutical industry, quality and regulatory compliance are not just standards; they are foundational pillars of our operations. We rigorously adhere to Current Good Manufacturing Practices (cGMP), which are legally enforced, ensuring full compliance with leading regulatory bodies, including Health Canada, the FDA (US), and the EMA (Europe). Our robust Quality Management System (QMS) underpins everything we do, encompassing comprehensive quality assurance (QA) and quality control (QC), meticulous documentation and change control, and proactive deviation and CAPA (Corrective and Preventive Action) management, all guided by thorough risk management. We proudly highlight our extensive experience with successful regulatory inspections and client audits. Furthermore, we provide extensive regulatory support, including assistance with regulatory submissions (e.g., NDA, ANDA), Drug Master File (DMF) support, and full compliance with serialization and track & trace regulations (like DSCSA in the US and similar regulations in Canada/EU), with pharmacovigilance support available if needed.