ELS Solutions - Regulatory & Quality

With strong technical and strategic expertise in Regulation and Quality Assurance.

Personalized Step-by-Step Service

Our main goal is to provide effective and comprehensive yet simple strategic solutions, including registrations in Europe, Brazil, and the rest of Latin America.

Europe

Quality

  • Quality Management Systems;
  • Good Distribution Practices;
  • Audits.

Regulatory Affairs

  • Medical Devices;
  • Medicines;
  • Cosmetics;
  • Dietary Supplements;
  • Medical Cannabis;
  • Other Products.

Medical Writing

Preparation of pharmaceutical, clinical, and non-clinical technical reports in accordance with current legislation and best practices.

Strategic Consulting

  • Development of regulatory strategies for Europe;
  • Definition of strategies for submission of registration processes for new products in Europe;
  • Opinions on regulatory strategies;
  • Project management;
  • Scientific advice Roadmaps.

Vigilance

  • Medical Device Vigilance;
  • Pharmacovigilance;
  • Cosmetovigilance;
  • Nutrivigilance.

Market Access

  • Development of strategy for pricing and reimbursement applications for pharmaceuticals.
  • Preparation, submission, and management of pricing applications.
  • Annual Price Review in accordance with guidelines issued by Competent National Authorities.
  • Exceptional Price Review requests.
  • Price amendment requests under the Notified Prices regime.
  • Preparation, submission, and management of reimbursement applications.
  • Development of therapeutic advantage dossiers.
  • Preparation of pharmacotherapeutic reports.
  • Preparation of clinical expert reports.
  • Conducting pharmacoeconomic studies.

LATAM

Quality

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

Regulatory Affairs

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

Medical Writing

Preparation of pharmaceutical, clinical, and non-clinical reports in accordance with current Brazilian and Latin American regulations, in regulatory and quality contexts.

Strategic Consulting

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

  • Development of a regulatory plan for market entry of products in Brazil and Latin America and advisory services for the same.
  • Definition of strategies for submission of registration processes for new products.
  • Regulatory strategy opinions.
  • Project management.
  • Scientific advisory.
  • Roadmaps.

Vigilance

  • Medical Device Surveillance;
  • Pharmacovigilance;
  • Cosmetovigilance;
  • Medical Cannabis Surveillance Services;
  • Food Surveillance Services;
  • Sanitary Surveillance Services;
  • In Vitro Diagnostic Products Surveillance Services.

Market Access

The Market Access process links global requirements with local country needs, requiring the following processes:

  • Value identification based on consumer information.
  • Value creation through clinical and health data on economic outcomes and research.
  • Value communication through Value Proposition and Value Dossier for R&D and Sales departments.

At ELS Solutions, we have professionals with international experience to assist your company in introducing your product to the Brazilian and Latin American market, creating a Market Access plan that includes:

  • Development and planning of strategies for market access in Brazil and Latin America.
  • Preparation of pharmacoeconomic studies.
  • Elaboration of pharmacotherapeutic reports.
  • Monitoring the entire process of product introduction in the Brazilian market, including post-market activities.

Other services

Distribution Headhunting

Aiming at the continuous expansion of the market of the Pharmaceutical and Health Industry companies with which it works, ELS Solutions plans, selects, attracts, negotiates and manages the most suitable distributor(s) for the target product of the customer in Europe and Latin America.

Importation

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.

Marketing Advisory

ELS Solutions carries out realistic, pragmatic and customized Market Studies for your company for your product or service in the target market, in Europe and Latin America.

Contact us

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