Lambda Canada | Regulatory History
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Regulatory History

Lambda to date has undergone more than 50 successful global inspections from the following regulatory bodies:

QA Functions

  • Independent QA function at all Lambda sites
  • Well-structured QA audits at pre-defined intervals to ensure data integrity
  • Regular system audits to facilitate continuous system improvements
  • Oversee inspections of various regulatory authorities
  • Handle regulatory/sponsors queries, recommendations through corrective/preventive actions, modifying and implementing our systems and processes wherever required
  • Conducting internal audits of study activities and data/reports and ensuring compliance as indicated by acceptance of the product dossiers (Regulatory submissions) by regulatory agencies
  • Manage sponsor audits for assessment of Lambda’s facilities & GCP/GLP compliance
  • Dedicated, qualified & well trained QA auditors
  • Teams with well-defined job responsibilities for conducting internal audits, document control and archival activities