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Pure Global, a leader in global market access services, and MEDIcept, known for its expertise in US and EU regulatory, quality, and clinical services, have announced their strategic collaboration. This alliance aims to revolutionise the medical device and in vitro diagnostics (IVD) industry by combining their strengths to unlock new opportunities and streamline market access worldwide.
Pure Global and MEDIcept say they recognise the paramount importance of regulatory compliance and market access for global success in the medical device and IVD sectors. By joining forces, the two entities aim to leverage their expertise and networks to navigate regulatory complexities efficiently. Pure Global brings to the table extensive experience in global representation and registration services alongside its AIGC regulatory tools.
Together, they provide comprehensive solutions ranging from regulatory affairs and quality assurance to clinical support and market representation across regions like the US, Latin America, Europe, the Middle East, and Asia Pacific.
The companies say this alliance is of 'significant' importance to the industry as it unites two companies with complementary strengths, enhancing their ability to navigate regulatory landscapes and facilitate market access effectively. By pooling their expertise, Pure Global and MEDIcept say they aim to drive growth and innovation, benefiting their clients and the industry as a whole.
Pure Global and MEDIcept are aligned in their pursuit of several objectives through this collaboration:
- Enhancing capabilities by leveraging respective networks and expertise
- Expanding service offerings into additional regions, including the US, 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
Both Pure Global and MEDIcept will continue their operations with an expanded service portfolio. The collaboration will see the companies leveraging their combined resources to enhance efficiency and deliver greater value to their clients.
The initial action following the alliance will involve a collaborative marketing effort to promote each other's services. By working together, Pure Global and MEDIcept aim to advance the medical device industry and remove barriers to innovation.
"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 & 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.
David Rothkopf, President of MEDIcept said: “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.”
