Quality Standards

International Standards You Can Trust

Every scientist at Royalmount Laboratories takes compliance with the Food and Drug Administration (FDA), Health Canada HC), European Medicines Agency (EMA), Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies, and 21 CFR Part 58 as a priority in all work performed. Quality documentation is 100% verified by Quality Control staff, and then thoroughly reviewed by Quality Assurance staff. This ensures your data is accurate and will remain valid.

  • FDA audited in May 2018 (no 483s);
  • HC GCP audited in February 2018;
  • SCC GLP accredited since 2015;
  • Numerous client and WHO representative audits.

Canadian Integrity meeting International Standards

Quality Services

Quality Assurance and Quality Control

Our Quality Services department is a stand-alone unit to provide assurance of regulatory compliance and 100% review of non-clinical and clinical study data. The Quality Services work with scientific staff and management to ensure Standard Operating Procedures (SOPs) and quality systems meet the latest requirements. The Quality Services have their own set of SOPs that define requirements for the inspection processes and that inspections occur on a timely manner:

  • Facility Inspections and Process Audits;
  • In Process Inspections;
  • SOP Audits;
  • Study Data Inspections;
  • Report Inspections.

Regulatory Agencies