About Axentra
Your Trusted Partner in Global Regulatory Compliance
Axentra Global Pharma Compliance is a U.S.–based regulatory consulting firm specializing in U.S. Agent services, FDA facility registration, drug listing, strategic regulatory guidance, dossier development, and GMP compliance support for pharmaceutical, nutraceutical, and contract manufacturing companies worldwide.
Who We Are
We were founded to solve a persistent industry gap:
foreign manufacturers struggle to navigate FDA systems, and regulatory consultants often need a reliable U.S.-based partner to handle facility registration, drug listing, and technical submissions.
Axentra brings together 60+ years of combined experience across regulatory affairs, GMP operations, product development, FDA pathways, and global regulatory frameworks. Our core team includes a technocrat with over four decades of pharmaceutical manufacturing leadership, a seasoned regulatory affairs expert with multinational experience, and a U.S.-registered pharmacist with 15 years of operational and regulatory exposure across retail, manufacturing, and compliance roles.
Together, we provide a uniquely integrated perspective—combining regulatory strategy, GMP practicality, and technical depth. We support companies through every stage of market entry: from U.S. Agent representation and establishment registration to scientific advice, CTD/eCTD dossier development, and inspection readiness.
Our Mission
Clear guidance, fast response, and technically sound solutions that help global manufacturers succeed in highly regulated markets.
Our Global Presence
Headquartered in the United States, with a strong operational alliance in India and Asia, Axentra serves clients across the U.S., EU, UK, Canada, Australia, and PIC/S countries—offering local insight and global coordination.
Whether you're preparing your first FDA submission, expanding into new global territories, evaluating a CDMO, or strengthening your compliance system, Axentra serves as a dependable extension of your regulatory and quality teams.