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AI Regulations in Healthcare: Global Definitions and Compliance Strategies
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Q&A

What is GSAP?

GSAP supports healthcare and life sciences organizations throughout the entire product lifecycle. We integrate multidisciplinary expertise across regulatory affairs, quality assurance, clinical research, engineering and validation with strategic thinking and hands-on execution to help organizations navigate complexity, achieve critical milestones, and bring healthcare innovations to the people who need them safely, efficiently, and at the right time

What are GSAP’s areas of expertise?

GSAP provides multidisciplinary expertise across regulatory affairs, quality assurance and QMS, clinical affairs and CRO, engineering and validation. We also support clients with specialized capabilities including non-clinical services, chemistry, manufacturing & controls (CMC), software documentation & compliance, cybersecurity, privacy & AI, scientific writing & communications, funding & grants, market access & reimbursement strategy, and professional training through GSAP Academy

Does GSAP offer professional training?

Through GSAP Academy, we provide professional courses in regulatory affairs, quality assurance, clinical research, engineering and validation. Organizations can also request tailored training programs customized to their specific needs, including real-world case studies and challenges from their own operations. Additional information is available on the Academy page

What does GSAP’s acquisition of HaMaDa mean for clients?

The addition of HaMaDa strengthens GSAP’s expertise in medical devices, IVD and digital health while expanding the range of expertise and services available to clients. Organizations now benefit from access to a broader team of specialists supporting medical devices, digital health (including SaMD, SiMD and AI-based technologies), diagnostics (IVD) and combination products, alongside GSAP’s expertise in regulatory affairs, quality assurance, clinical research and CRO, engineering and validation

What industries does GSAP support?

GSAP supports organizations across a broad range of healthcare and life sciences sectors, including biotechnology and pharmaceuticals, advanced therapies (ATMPs) and next-generation biotherapeutics, medical devices, digital health, IVD, combination products, hospitals, laboratories, academic institutions, FoodTech and medical cannabis

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