Expert Product Development, Quality, Regulatory, and Operations Management Consulting
Specializing in FDA GMP compliance, submissions, and approvals for Class III PMAs, Class II 510(k)s, and the De Novo pathway for medical devices and IVDs, with a strong emphasis on quality, safety, and successful commercialization.
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Get in touch for expert consulting and regulatory support today.
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Ascent Biomedical is strategically headquartered in the heart of innovation, empowering medical device and IVD companies with expert consulting services in Quality Assurance, Regulatory Affairs, and Clinical Affairs. Our team specializes in navigating complex global regulatory landscapes, ensuring full compliance with FDA GMP/QSR, CLIA, NY CLEP, ISO 13485, ISO 15189, EU MDR, and EU IVDR standards.
GLOBAL HQ - USA
9900 Broadway St., 2241
Pearland, TX, USA
Hours
Monday through Friday 9 AM - 5 PM CST
Locations
APAC Regional HQ - INDIA
Hours
Monday through Friday 9 AM - 5 PM IST
141/23A, Mangala Nagar, 5th Cross Street, Mangala Nagar, Porur, Chennai, Tamilnadu, INDIA