Pure Global

About Pure Global

Pure Global key features

• Comprehensive market access services across 30 countries, including local representation and registration support.
• Advanced AI technology for efficient technical document management and regulatory compliance.
• End-to-end clinical trial management services, covering pre-market and post-market phases.
• Continuous regulatory monitoring and post-market surveillance to ensure ongoing compliance.
• Tailored solutions for medical device manufacturers of all sizes, from startups to multinational enterprises.

Pure Global use cases

• Provide market access solutions for medical device manufacturers to navigate regulatory compliance in over 30 countries.
• Offer clinical trial management services, including study planning, execution, and post-market surveillance for medical devices and IVDs.
• Utilize AI and data tools to enhance the efficiency of technical document management and regulatory submissions.
• Serve as local representatives for medical device companies, ensuring compliance with local regulations and facilitating communication with regulatory authorities.
• Conduct market research and analysis to identify opportunities for expansion and inform regulatory strategies for clients.

Useful for

• Provides comprehensive market access solutions for medical device companies, facilitating entry into multiple global markets.
• Offers expert regulatory guidance to navigate complex compliance requirements, reducing the risk of application rejections.
• Utilizes advanced AI and data tools to streamline the documentation and submission process, enhancing efficiency and accuracy.
• Delivers end-to-end clinical trial management services, ensuring compliance and effective data collection throughout the trial phases.
• Maintains continuous regulatory monitoring and post-market surveillance to ensure ongoing compliance and product safety.

Price

• Pure Global offers local representation and registration services across 30 countries.
• The company provides comprehensive solutions for market registration, regulatory services, quality assurance, local representation, and clinical services.
• They assist with securing approvals and certifications from regulatory bodies to ensure products are ready for market entry.
• Their services include post-market surveillance and vigilance to monitor the safety and efficacy of medical devices and IVDs.
• Pure Global utilizes advanced AI technology to enhance the efficiency of technical document management and regulatory compliance.