Expertise in global market access & regulatory compliance for medical devices, in-vitro diagnostics, SaMD, and AI technologies.
Partner with us to streamline your market access and regulatory compliance efforts, minimizing the risk of application rejections and reducing unnecessary costs.
We assist you with identifying which markets to expand to leveraging existing registrations and approvals.
Our local regulatory experts provide strategic support to determine classification of your product portfolio and the number of registrations that are required.
Based on the classification of your products, we can outline the required steps and information to obtain your registration.
Our advanced AI technology enhances the efficiency of technical document management, ensuring accuracy, completeness, and regulatory compliance.
Compilation of the technical dossier
Supported by advanced AI technology, our regulatory team streamlines the document collection and compilation process ensuring a smooth and efficient workflow.
Submission to the regulatory authority
Our local regulatory experts in each market interact with the local authorities to submit and obtain your registration certificate.
We deliver comprehensive post-market surveillance and vigilance to monitor the safety and efficacy of medical devices and IVDs.
Local representation
As your representative we are the local contact for authorities to reach out to for any questions or concerns about your products on the market.
Continuous regulatory monitoring
Regulations change constantly and we will monitor and inform you of any changes that may impact market access .
From regulatory compliance to conquering new markets, our comprehensive solutions are designed to meet every challenge in your journey.
We guide you through securing approvals and certifications from regulatory bodies, ensuring your product is ready for market entry.
We create efficient strategies for regulatory approval, providing advice on pathways and pre-submission activities.
We guarantee your products meet international quality standards and compliance requirements, both before and after market entry.
We establish our own operations in key markets worldwide, offering direct insight and support for local compliance and market entry.
We offer end-to-end clinical trial management, covering everything from pre-market development to post-market surveillance.
We offer market analysis, lifecycle management, and targeted training to navigate global healthcare markets effectively.
When you partner with Pure Global, a single registration process opens doors to multiple markets. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
