China's Best One-Stop Medical Equipment Provider
About

Medical Device Regulatory Affairs . Consulting and Management We are a consulting company specialized in Medical Device Regulatory Affairs, formed by a multidisciplinary team of professionals with over 20 years of experience in the public and private sector. We provide consulting services on a national an international scale, streamlining the access to new markets with custom solutions according to your company´s needs. Our services are focused on Latin American countries: Argentina, Brazil, Mexico, Colombia, Ecuador, among others. The scope of our services extends to Europe and United States Our main services: - Centralized coordination and regional management of Regulatory Affairs - Medical device registration - Specialized technical translations - Facility design - Quality management - Internal and external audits - Online project control

Technologies
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Keywords
regulatory affairs & consultancy consultancy regulatory affairs medical equipment manufacturing iso 13485 clinical trials product approval consulting regulatory audits troubleshooting regulatory issues clinical evaluation services regulatory system certification fda registration support gmp compliance regulatory consultancy for food and cosmetics product design product development gmp product compliance consulting regulatory guidance cosmetics latin america regulatory process optimization product registration regulatory dossier preparation food & beverage regulatory documentation regulatory submissions translation of technical documents
Company Information
  • Employees 8
Location

1946 Tucuman, Buenos Aires, Buenos Aires, Argentina, C1050

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