ELSAqr Brazil/LATAM

PRODUCT

  • Good Manufacturing and Laboratory Practices;
  • Quality Management Systems (QMS);
  • INMETRO certifications;
  • ISO certification.

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  • Medical Devices;
  • Medicines;
  • Cosmetics;
  • Foods;
  • Medicinal Cannabis;
  • Sanitizing;
  • In Vitro Diagnostic Products;
  • Other products.

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At ELS Solutions we have professionals with international experience to assist your company through:

  • Realization of a regulatory plan for the entry of products in the Brazilian market and advice to them;
  • Defining strategies for submitting new product registration processes;
  • Opinions on regulatory strategies;
  • Project management;
  • Scientific adviser;
  • Roadmaps.

Preparation of pharmaceutical, clinical and non-clinical reports, in accordance with current Brazilian legislation, in terms of regulation and quality.

  • Surveillance of Medical Devices;
  • Pharmacovigilance;
  • Cosmetovigilance;
  • Surveillance Services for Medicinal Cannabis;
  • Food Surveillance Services;
  • Sanitizing Surveillance Services;
  • Surveillance of in vitro diagnostic products.

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The Market Access process links requirements at the global level and needs at the local country level. In need of:

  • Value identification, based on consumer information;
  • Creating value through clinical and health data on economic results and research;
  • Communication of value through the Value Proposition and Value Dossier, for the R&D and Commercial departments.

We at ELS Solutions have professionals with international experience assisting your company with the introduction of your product in the Brazilian market, creating a Market Access plan:

  • Preparation of pharmacoeconomic studies;
  • Development and planning of strategies for access to the Brazilian market;
  • Preparation of pharmacotherapeutic reports;
  • Monitoring the entire process of introducing the product to the Brazilian market, in addition to the post-market.