Services
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Market Access

Global Representation & Registration Services

We specialize in global market access and regulatory compliance solutions, focusing on medical devices, in-vitro diagnostics, SaMD (software as a medical devices), and artificial intelligence (AI).

Regulatory Strategy
and Pathway

Partner with us to streamline your market access and regulatory compliance efforts, minimizing the risk of application rejections and reducing unnecessary costs.

regulatory strategy

Global market research

We assist you with identifying which markets to expand to leveraging existing registrations and approvals.

Registration strategy

Classification And grouping

Our local regulatory experts provide strategic support to determine classification of your product portfolio and the number of registrations that are required.

Requirements strategy

Market access requirements

Based on the classification of your products, we can outline the required steps and information to obtain your registration.

Accessing Markets

Submission and 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.

Maintaining market presence

Post-Market Surveillance

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 .

our offer

One-Stop International Registration

From regulatory compliance to conquering new markets, our comprehensive solutions are designed to meet every challenge in your journey.

Market Registration

We guide you through securing approvals and certifications from regulatory bodies, ensuring your product is ready for market entry.

Regulatory Services

We create efficient strategies for regulatory approval, providing advice on pathways and pre-submission activities.

Quality Assurance

We guarantee your products meet international quality standards and compliance requirements, both before and after market entry.

Local Representation

We establish our own operations in key markets worldwide, offering direct insight and support for local compliance and market entry.

Clinical Services

We offer end-to-end clinical trial management, covering everything from pre-market development to post-market surveillance.

Other Services

We offer market analysis, lifecycle management, and targeted training to navigate global healthcare markets effectively.

Single Process,
Multiple Markets

When you partner with Pure Global, a single registration process opens doors to multiple markets. Our global subsidiaries make this streamlined path possible.

Contact us
Request information

Let's Talk,
Anywhere You Are.

Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.

Our closest representative will get back to you within 24 hours.
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