Audit Services
Pharmaceutical and biotech companies operating in distribution environments face constant pressure to maintain GDP compliance across complex, multi-party supply chains. Regulatory inspections arrive with little notice, and the consequences of non-compliance can devastate operations and reputation. Yet many organizations struggle with fundamental challenges: internal teams lack objectivity to identify their own compliance gaps, personnel knowledge varies widely across roles and locations, third-party suppliers operate outside direct organizational control, and inspection anxiety prevents teams from performing optimally under regulatory scrutiny.
Without systematic assessment and structured competency development, compliance vulnerabilities remain hidden until regulators expose them. Organizations need proactive approaches that identify weaknesses before inspections occur and build the knowledge required to maintain standards consistently.
Our GDP Audit and Training services provide integrated assessment and capability development that strengthens compliance infrastructure while building organizational competence. We deliver comprehensive audit programs that objectively evaluate your operations against GDP requirements, combined with targeted training that addresses identified knowledge gaps and builds genuine understanding of regulatory expectations.
Internal Audits – We conduct systematic compliance reviews across all GDP elements: documentation systems, storage and handling conditions, distribution processes, equipment qualification and maintenance, personnel competency, and supplier controls. Our audit teams provide objective evaluation using risk-based methodologies that prioritize findings by compliance impact. Each audit delivers actionable reports with practical remediation recommendations that account for operational realities and resource constraints.
External Audits – We assess suppliers, logistics providers, contract warehouses, and other third-party partners who handle your products. These comprehensive audits evaluate facilities, quality systems, and operational practices against GDP standards, providing documented evidence that satisfies regulatory expectations for supplier oversight and due diligence.
Mock Inspections – We replicate the regulatory inspection experience, adopting inspectors' perspectives and using actual regulatory checklists. These simulations prepare your teams for real inspections, reduce anxiety, clarify regulatory expectations, and identify remaining vulnerabilities that require attention.
Audit Follow-Up – We ensure findings translate into genuine improvements through sustained remediation support. Our team helps develop effective corrective action plans, verifies implementation quality, and confirms actions achieve intended outcomes.
Training Programs – We build real competence through targeted programs developed from competency assessments. Our GDP fundamentals training ensures all personnel understand distribution requirements, their specific responsibilities, and the critical importance of maintaining product integrity. Training addresses different learning styles and organizational roles, creating genuine compliance mindset rather than rote procedure-following.
Effective compliance requires both knowing where you stand and building the capability to improve. Our integrated audit and training services provide the systematic assessment and competency development that transform compliance from vulnerability into competitive advantage.
Contact us today to discover how our GDP audit and training services can strengthen your compliance infrastructure and prepare your organization for regulatory success.
