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ABOUT APAC FDA
NEWS
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Difference
APAC FDA
The most efficient services.
The most qualified professionals.
Since 2024, APAC FDA Consulting multidisciplinary team of highly experienced FDA consultants and industry experts has offered compliance, regulatory affairs, and science & technology services to clients around the world.
AREAS SERVED BY APAC FDA CONSULTING
ADVANCE. CONFIDENTLY.
As long-standing leaders in technical and regulatory consulting services, APAC FDA Consulting provides both experience and excellence through an unmatched team of respected industry professionals and SMEs.
PHARMACEUTICAL
APAC FDA Consulting has an unsurpassed reputation for excellence in technical, regulatory consultations, and guidance services for the Pharmaceutical Industry, including generic and novel drug products. OIC, and monograph drugs, and many more.
MEDICAL DEVICE/
COMBINATION PRODUCTS
APAC FDA Consulting comprehensive list services extend to all classes of medical devices and combination products including In Vitro Diagnostics, Integral, Cross-labeled and Kitted Combination Products.
BIOLOGICS
APAC FDA Consulting has a reputation for demonstrated excellence in technical, regulatory consulting, and guidance services for biologics, including cell and gene therapy, human cell and tissue products, monoclonal antibodies, biosimilars and many more.
REGULATORY AFFAIRS
APAC FDA Consulting Regulatory Affairs group is comprised of former senior label FDA managers, FDA reviewers, and Industry experts. Their goal is simple; provide simple workable solutions for client’s regulatory problems or issues at the highest levels of efficiency and excellence.
Are you fully prepared for an inspection at your facility?
Mock FDA Inspections
Our team of experienced ex-FDA investigators offer comprehensive mock FDA inspection services to help you prepare for an actual FDA inspection. Our team of experts will conduct a thorough inspection of your facility, review your documentation, and provide you with valuable feedback on areas that need improvement to ensure compliance with FDA regulations – both remotely and on-site.
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