Axxion Regulatory Advisory Company Profile, Contacts & Intelligence

Axxion Regulatory Advisory Overview

Axxion Regulatory Advisory is a specialized spin-off of Axxion Consultoría Aplicada, a consulting firm with 16 years of experience in regulatory and quality services for the medical, food, cosmetics, and related industries. At Axxion Regulatory Advisory, we are an interdisciplinary team of professionals specialized in regulatory compliance for medical devices, supporting developers and companies in a highly demanding and fast-evolving regulatory environment. Our strength lies in our wide experience, highly committed professionals, strong execution and analytical skills, and our proven ability to guide clients and partners through complex regulatory processes. We offer expert support in: * Development, implementation, maintenance, and auditing of quality systems based on ISO 13485 and Good Manufacturing Practices (GMP). * Product registration with multiple international regulatory authorities (e.g., FDA, ANVISA/INMETRO, CE marking, among others). * Regulatory strategy for market entry and lifecycle management. * Product compliance assessment and preparation of technical documentation (risk management, usability, software documentation, among others). * Coordination with testing laboratories and certification bodies (e.g., notified bodies) 📍 Find us at: www.axxionregulatory.com & www.axxionconsultora.com.ar

Headquarters

Córdoba, Ar

Website

axxionregulatory.com

Industry

Business Consulting And Services

Founded

2009

Stock Symbol

IS

NAICS

Management, Scientific, and Technical Consulting Services, Management Consulting Services

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