Other services
Comprehensive services consultancy in foreign trade and risk management
ANMAT Registration
- Authorization of importing company and/or manufacturer of medical products
- Medical Product Consulting
- We define the safety and efficacy of your medical product and compliance with regulatory requirements.
Consulting and services
Medical Product Registrations
We collaborate in the preparation of your Design Records and Technical Files (Product Master Records) in accordance with national and international regulatory requirements (ANMAT, FDA, Europe).
RNE / RNPA
RNE
Quality Management
We design and implement your system in accordance with ISO 9001 and ISO 13485 standards and develop specific documentation. We audit your quality management system and collaborate with the development of your suppliers.
Risk Management Plan
We design and implement in compliance with the requirements of the ISO 14971 standard. We identify hazards and risks in products and manufacturing processes and implement measures to mitigate and remediate risks.
Good Manufacturing Practices
We develop and implement your GMP system in accordance with the requirements of ANMAT, FDA and European Community Provision 3266/13.
Essential Safety and Effectiveness Requirements
We determine the requirements based on the information from the Risk Management Plan and the different engineering areas. We prepare the documentation in accordance with the applicable regulatory requirements.
Imports
Door to Door
Service
Door-to-door imports are a type of logistics service that consists of receiving merchandise in the country of origin, transporting it to the country of destination and final delivery to the place indicated by the importer.
- Collection of the merchandise at the place of origin.
- Export procedures in the country of origin.
- International transport (air or sea).
- Import procedures in the country of destination.
- Delivery of the merchandise to the place indicated by the importer.
Our Partner in Imports
Door to Door
AMLOG has logistics coverage in more than 160 countries
- Customs services
- Interactive logistics
- Maritime transport
- Air transport
- Ground transportation
- Bonded warehouse
- Free Zone
- Warehousing
- Shipment Tracking
We are ready to assist you in your next project.
Let's talk!
Do you have any questions or comments? Let us know.
Our opening hours:
Monday to Friday from 10 a.m. to 6 p.m.
info@sconsultora.com.ar
Call us:
549 1126146550
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