- Good Manufacturing and Laboratory Practices;
- Quality Management Systems (QMS);
- INMETRO certifications;
- ISO certification.
- Medical Devices;
- Medicinal Cannabis;
- In Vitro Diagnostic Products;
- Other products.
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;
Preparation of pharmaceutical, clinical and non-clinical reports, in accordance with current Brazilian legislation, in terms of regulation and quality.
- Surveillance of Medical Devices;
- Surveillance Services for Medicinal Cannabis;
- Food Surveillance Services;
- Sanitizing Surveillance Services;
- Surveillance of in vitro diagnostic products.
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.