Pure Global, a provider of global market access services, and MEDIcept, a consultancy offering U.S. and EU regulatory, quality, and clinical services, are joining forces to support regulatory compliance and speed market access for medical device and in vitro diagnostics (IVD) providers.

Pure Global brings to the table extensive experience in global representation and registration services alongside their AIGC regulatory tools. MEDIcept boasts a solid reputation in regulatory, quality, and clinical services for the U.S. and EU markets. Together, their goal is to offer comprehensive solutions ranging from regulatory affairs and quality assurance to clinical support and market representation across regions including the U.S., Latin America, Europe, the Middle East, and Asia Pacific.

The two companies’ objectives through this collaboration include:

• Enhancing capabilities by leveraging respective networks and expertise
• Expanding service offerings into additional regions, including the U.S., Europe, the Middle East, Latin America, and Asia-Pacific
• Leveraging each other’s strengths to bolster capacity and expertise
• Designing pre- and post-market global clinical studies for comprehensive support
• Empowering research efficiency through Pure Global’s AIGC tools

“Pure Global’s strategic alliance with MEDIcept will help accelerate MedTech innovation and streamline compliance. By combining their hundreds of successful submissions since 1996 with our AI-powered and data driven regulatory solutions, we empower clients worldwide to bring life-changing MedTech to market faster, with reduced costs and higher regulatory success.” said Zhu (Phyllis) Meng, CEO of Pure Global.

“With this strategic alliance we are strengthening our worldwide presence and can serve the needs of our customers anywhere. With teams of seasoned consultants both MEDIcept and Pure Global offer deep expertise across a wide range of compliance needs. Together, this relationship will efficiently help international companies with FDA and US quality, regulatory, clinical, and reimbursement concerns and rapidly provide tailored, trusted solutions to meet their unique challenges,” said David Rothkopf, President of MEDIcept.