Services for Supplements and Foods
Product Regularization: initiation of manufacturing and importation communications, notifications and registrations
Inclusion of New Ingredients in positive lists, particularly with EFSA as Novel Foods
Preparation of dossiers for obtaining GRAS Status
Regulatory framing (classification) of products
Nutrivigilance
Review of assessment, communication, notification and registration processes
Preparation of petitions for safety and efficacy assessment
Registration of raw materials of animal origin
Issuance of health licenses/authorizations for companies
Evaluation of formulas regarding sanitary health requirements
Approval for the use of New Ingredients
Regulation services on new foods - (NFR)
DGAV Certifications
Free Sale Certificate for Food Supplements - DGAV
Export Certificate – DGAV
Preparation and review of labeling texts
Review of label artwork and advertising materials
Support in responding to technical requirements, notifications and sanitary infractions
Regulatory impact assessment
Regulatory-strategic support
Documentation Gap Analysis
Clarification of technical doubts
Preparation of regulatory advices
Feasibility report preparation for regularization of supplements and foods
Review of toxicological studies for safety determination
Guidelines for conducting toxicological studies
Review of clinical studies for efficacy determination
Guidelines for conducting clinical studies
Assistance in creating and maintaining a post-market monitoring system Training
Registration Renewal
Post-registration Changes
Regulatory consultancy in Importation and Exportation
other services
Regulatory & Quality
ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.
Distribution Headhunting
ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.
Import
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.
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