Services for Food Supplements
Analysis of technical documentation against health requirements
Regulatory assessment of the production process
Review of toxicological studies to determine safety
Evaluation of specifications
Guidelines for conducting toxicological studies
Review of clinical studies to determine efficacy
Guidelines for conducting clinical studies
Evaluation of formulas against health requirements
Labeling design and review of label artwork
Assistance in developing specification monographs
Risk Analysis - Determine the correct classification of food supplements according to local regulatory body
Drafting regulatory opinions
Registration Renewal
Post-registration changes
Training and Education
Compliance Audits
Import and Export Advice
Conformity assessment
Document Management
Equivalence Assessment
Regulatory-strategic support
Clarifying technical doubts
Gap analysis
Preparation of feasibility reports
Regulatory Impact Assessment
Regulatory support for food imports and exports
Issuing health licenses/permits
Submitting consultations on new foods to local regulatory body
Notice of start of import
Notification of products to local regulatory body
Preparation and review of the technical dossier required for registration of Food Supplements with local regulatory body
Preparation of petitions for the evaluation of safety and efficacy
Support in responding to requirements
Review of evaluation, communication, notification and registration processes
Assistance in setting up and maintaining a post-market monitoring system
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.
Contact us
Your success is our business