GlobalReg Solutions

With over 25 years of experience, at GlobalReg Solutions, we specialize in medical devices, digital health, and pharmaceutical quality and regulatory services, guiding companies through the complex landscape of global quality and regulatory compliance. Or expertise spans FDA, EU MDR, Health Canada, LATAM, EMEA, ASEAN, and APAC international frameworks, ensuring your innovations reach markets efficiently, compliantly, and confidently. Whether you're an early-stage startup or an established company, we deliver tailored regulatory, investment, and reimbursement solutions. Regulatory Services: Regulatory Pathway & Strategy: Regulatory Pathway Consulting FDA, EU MDR, and Global Approval Roadmaps for startups and enterprises. 510(k), De Novo, PMA, and CE Mark Submissions with expert regulatory filings and clinical evaluations. SaMD compliance, including IEC 62304, cybersecurity, and AI guidelines Regulatory Due Diligence: Comprehensive risk assessments ensure sound MedTech investment decisions. In-depth clinical, technical, and market readiness evaluation for potential MedTech investments. Quality Compliance: QMS Implementation (ISO 13485, 21 CFR Part 820, MDSAP) for global market readiness. Post-Market Product Support and Compliance Management: Post-Market Surveillance & Vigilance Reporting Risk Management & Compliance (ISO 14971) Regulatory Dossier Updates & Maintenance Labeling & IFU Compliance Internal & External Audit Preparation Supplier & Manufacturing Compliance Device Registration & Renewals Market Expansion Regulatory Strategy Software Lifecycle & Cybersecurity Compliance AI-Based Medical Device Regulatory Support

• Employees0
• Founded2022