Regulatory & Quality

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

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

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

• 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.

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

• 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.

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

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

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

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.

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

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.

• ARGENTINA: National Administration of Medicines, Food and Medical Technology (ANMAT)
• BRAZIL: National Health Surveillance Agency (ANVISA)
• CHILE: National Medicines Agency (ANAMEd)
• COLOMBIA: National Institute for the Surveillance of Medicines and Food (INVIMA)
• MEXICO: Federal Commission for the Protection against Sanitary Risks (COFEPRIS)
• EUROPE European Medicines Agency (EMA)
• PORTUGAL: Portuguese Medicines and Health Products Authority I.P. (INFARMED)
• FRANCE: National Agency for Medicines and Health Products Safety (ANSM)
• SPAIN: Spanish Agency of Medicines and Health Products (AEMPS)
• UK: Medicines and Healthcare Products Regulatory Agency (MHRA)
• ITALY: Italian Medicines Agency (AIFA)
• ALEMANHA: Federal Institute for Drugs and Medical Devices (BfArM)