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

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Keywords
regulatory affairs & consultancyconsultancyregulatory affairsmedical equipment manufacturingiso 13485clinical trialsproduct approvalconsultingregulatory auditstroubleshooting regulatory issuesclinical evaluationservicesregulatory system certificationfda registration supportgmp complianceregulatory consultancy for food and cosmeticsproduct designproduct developmentgmpproduct compliance consultingregulatory guidancecosmeticslatin americaregulatory process optimizationproduct registrationregulatory dossier preparationfood & beverageregulatory documentationregulatory submissionstranslation of technical documents
Company Information
  • Employees8
Location

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

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