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
Company Details
- Employees
- 2
- Founded
- -
- Address
- Córdoba, Córdoba 5000, Ar
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://axxionregulatory.com/
- Keywords
- Regulatory Affairs for Medical Devices, ISO 13485, Quality Management Systems, Establishment Registration, CE Mark, FDA, ANMAT, GMP, MDR.
- HQ
- Córdoba, Córdoba
Axxion Regulatory Advisory Questions
Axxion Regulatory Advisory's website is http://axxionregulatory.com/
Axxion Regulatory Advisory's LinkedIn profile is https://ar.linkedin.com/company/axxionregulatory
Axxion Regulatory Advisory has
2 employees.
View email and phone details for 2
employees at Axxion Regulatory Advisory.
Axxion Regulatory Advisory's industry is
Business Consulting and Services
Axxion Regulatory Advisory's top competitors are
Deam,
Analyzer - Ingeniería Aplicada,
Icu Medical,
Gs Bio Implantes Quirúrgicos S.a,
Nativa S.r.l.,
Denimed Ltd,
Ottaa Project,
Mmgc Srl,
Life Si,
Crecer | Biotecnología Ortopédica.
Axxion Regulatory Advisory's categories are Business Consulting and Services
Axxion Regulatory Advisory's founding year is 2009
