The two companies are enhancing their ability to navigate regulatory landscapes and effectively facilitate market access.
This article was originally published in Medical Product Outsourcing.
Pure Global is teaming up with MEDIcept to unlock new opportunities and streamline market access in the medical device and in-vitro diagnostics (IVD) industries.
The two companies aim to leverage their expertise and networks to efficiently navigate regulatory complexities. Pure Global claims it has extensive experience in global representation and registration services as well as cutting-edge AIGC regulatory tools; MEDIcept, meanwhile, boasts a solid reputation in regulatory, quality, and clinical services for the U.S. and EU markets. Together, they provide comprehensive solutions ranging from regulatory affairs and quality assurance to clinical support and market representation across various regions—the United States, Latin America, Europe, the Middle East, and Asia Pacific, the firms contend.
“Pure Global’s strategic alliance with MEDIcept will help accelerate medtech innovation and streamline compliance. By combining their hundreds of successful submissions 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,” Pure Global CEO Zhu (Phyllis) Meng said.
The alliance unites two companies with complementary strengths, enhancing their ability to navigate regulatory landscapes and facilitate market access effectively, executives said. By pooling their expertise, Pure Global and MEDIcept aim to drive growth and innovation, ultimately benefiting clients and the industry.
Pure Global and MEDIcept are aligned in their pursuit of several objectives through this collaboration:
Both Pure Global and MEDIcept will continue their operations with an expanded service portfolio. 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. “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,” MEDIcept President David Rothkopf stated. Established in 2020, Pure Global considers itself a global growth partner to medtech companies, delivering smart, efficient market access solutions powered by transformative data and technology. The company has served more than 300 clients globally and has over 1,900 global registration certificates.MEDIcept has provided regulatory, quality, and clinical services for medical device and IVD manufacturers worldwide since its 1996 inception. The company is credited with more than 600 submissions, 1,000 audits, 50 clinical trials, and a successful track record of remediation activities.
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