Quality Assurance Services
ISO 13485:2016 QMS Certification
ISO 14971:2019 QMS Certification
ISO 9001:2015 QMS Certification
Quality Management Systems (QMS)
Development of SOPs (Standard Operating Procedures)
Pre-Inspection
Audits and Inspections - Simulation and accompanying with local regulatory agency
Good Distribution Practice Certification
Good Manufacturing Practice Certification
EU GMP Certification
Good Import Practices Certification
Good Laboratory Practice Certification
Field Action in Technovigilance
Post-Market Surveillance and Monitoring of Medical Devices
Pharmacovigilance
Cosmetovigilance
Nutrivigilance
Quality Strategy, Implementation and Improvement
CAPA Plan - Support for investigations and deviations
Good Documentation Practice
Quality Strategy, Implementation and Improvement
Design and development of new products
Technical Writing
Medical Writing
Training for operational and regulatory team
other services
Regulatory & Quality
ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.
Distribution Headhunting
ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.
Import
ELS Solutions provides a robust Import, Warehousing, Billing and Customer Service service, in the countries where it is represented, so that the customer controls their business, their margin and does not need to depend on the distributor, focusing on increasing of sales.
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