Auditing & QA Services

Drug Safety Consult offers to audit Pharmacovigilance, Clinical Development and PASS activities and systems for GVP and GCP compliance towards ICH Standards as set forth by EMA, FDA and other applicable regulations. The validation and maintenance of E-system used, will be assessed for compliance with predicate rules and contribution to the regulated processes

Drug Safety Consult can assist you via pre inspection audits in the preparation for e.g. an MHRA or EMA inspection.

Audits and assessments in English. ISO examined lead auditor.

Based on audit observations Drug Safety Consult can assist in any corrective and preventive activities to be undertaken, and in developing quality plans for regulated areas; the scope being a quality management system that is robust, consistent, and transparent and provide clear and timely solutions throughout the organisation.


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