Ideagen CompliancePath Reviews & Provider Details

CompliancePath is an end-to-end health and life science compliance services provider supporting international organizations across the life science community in the US, Europe, China and Australia. Founded in 2008, the company operates from service centers in Glasgow, Scotland and Bridgetown, Barbados, delivering specialized consulting services to pharmaceutical, biotechnology, medical device, and healthcare organizations worldwide. Core Service Offerings: Computer System Validation (CSV) and Computer Software Assurance (CSA) consulting ISO 27001, ISO 9001, and SOC 1/2/3 certification preparation services Data integrity assessments and GDPR, HIPAA, HITRUST compliance consulting Software as a Medical Device (SaMD) validation and FDA guidance alignment support The CompliancePath team manages validation projects for GMP, GLP, GCP, and QA/QC software applications using a risk-based methodology aligned with FDA Computer Software Assurance guidance. Services include software hazard analysis, validation accelerator packages, and comprehensive audit support. The company provides transparent project management, virtual meeting capabilities, and remote delivery options for global project execution. Why Organizations Choose CompliancePath Accelerated Validation: Reduce validation timelines from 6-8 months to 4-6 weeks using risk-based Computer Software Assurance approaches. Most validations are completed in approximately 15 days through streamlined processes. Industry Expertise: ISACA-certified team with CISA, CRISC, and CDPSE designations. Active participation in ISPE GAMP steering committees and industry trade associations. The senior team has performed data integrity training directly to the US FDA. Cost-Effective Delivery: Projects typically cost 30-50% less than US-based competitors through efficient remote delivery models and transparent fixed-cost structures. What Makes It Different GxP Specialization: Built specifically for regulated industries with deep understanding of FDA, EMA, and other regulatory requirements. The company focuses exclusively on life sciences compliance rather than general IT consulting. Risk-Based Methodology: Uses ISPE GAMP-based approaches aligned with FDA Computer Software Assurance guidance, reducing unnecessary validation overhead while maintaining regulatory compliance. Global Remote Delivery: Delivers 95% of projects remotely from centers of excellence across international time zones, providing consistent quality and cost efficiency. Who Uses CompliancePath 🧬 Life Sciences & Pharmaceuticals GxP compliance and computer system validation 🏥 Healthcare Organizations HIPAA, HITRUST, and healthcare IT governance 🏢 Medical Device Companies Software as a Medical Device validation and IEC 62304 compliance 💼 Technology Companies ISO certifications and SOC compliance 🏛️ Regulated Industries IT governance frameworks and regulatory compliance