Why Axentra Global Pharma Compliance is Your Best Choice for Pharmaceutical Market Entry
01.
Decades of Practical Regulatory and GMP Expertise
Our leadership brings 60+ years of combined experience across regulatory affairs, GMP systems, and on-ground manufacturing operations.
02.
A True U.S. Presence for Global Clients
With a reliable U.S. address, dedicated FDA mailbox, and responsive communication, Axentra ensures seamless interactions with regulators.
We combine local FDA representation with international expertise, helping clients achieve compliance in the U.S., EU, UK, Canada, Australia, and PIC/S markets.
03.
Integrated Support Across the Drug Lifecycle
From facility registration and drug listing to strategy, dossier development, and compliance—we support you at every regulatory checkpoint.
04.
Built for Manufacturers, CDMOs & Consultants
We work not only with foreign manufacturers, but with regulatory consultants who outsource U.S. Agent, registration, SPL, and GMP tasks.
05.
Every submission, SPL, or registration is handled with speed, accuracy, and a scientific approach tailored to your product and markets.