
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.