Innovative product manufacturers face strict regulatory hurdles and are expected to show solid financial return faster than ever. At the same time, the evolving regulatory landscape requires vigilance and expert guidance to stay compliant. IcGXP is a full-service consulting firm that provides expert compliance auditing, risk management and quality system development services meeting the needs of firms from product development through commercialization. We develop programs that are client-specific and results-oriented to get your company in compliance – and keep you there – while helping to improve quality and achieve profitability. And because we understand that companies have both short- and long-term needs, IcGXP develops cost-effective plans that are flexible and scalable to effectively meet changing priorities, issues and resources. IcGXP’s diverse portfolio of strategic compliance and risk management services includes: Compliance Auditing – Audit readiness evaluations, gap analysis, quality system assessments and formal audits for key quality and manufacturing systems under CFR 210/211, CFR 820, GCP, EU cGMP Directives, ISO13485, QMS/PAL and CMDCAS regulations. Quality System Development – Development and enhancement of new and existing quality systems including but not limited to: re-engineering and assessment of Standard Operating Procedures, QA management and management control systems, CAPA systems, Complaint handling systems, Change control and configuration management and validations systems. Contract Manufacturing and Business Alliance Quality – Contract manufacturing sourcing and qualification, service evaluations and quality agreements. Due diligence evaluations for the purchase or license of products, services and facilities.