Regulatory History

Lambda to date has undergone more than 30 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