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
Services for Medical Devices:
Risk Analysis - Determine the correct classification of medical devices according to local regulatory body
Preparation and review of the technical dossier required for registration of Medical Devices with local regulatory body
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
Good Manufacturing Practice (GMP) Compliance Assessment
Analysis of Clinical Studies
Verification of Labeling Requirements
Evaluation of Registration Documents obtained in other countries
EU MDR Transitions
Advice on Testing and Certification
Assistance in obtaining Local Regulatory Body Certification
Assistance in obtaining INMETRO Certification in Brazil
Assistance in obtaining ISO 13485 Certification
Support in preparing for Regulatory Inspections
Review of regulatory documents
Assessment of Quality Control and Manufacturing Requirements
Assistance in obtaining CE Certification
Advice on Complaints and Recalls
Post Market Clinical Follow-up
Services for Drugs
Update Certification of Good Practices for Pharmaceutical Ingredients
Cancel Registration of Active Pharmaceutical Ingredient
Preparation and review of the technical dossier required for registration of Pharmaceutical Ingredients with local regulatory body
Renew Certification of Good Manufacturing Practices for Pharmaceutical Ingredients
Change Active Pharmaceutical Ingredient Registration
Change Certification of Good Practices for Distribution and Storage of Pharmaceutical Ingredients
Change Certification of Good Manufacturing Practices for Pharmaceutical Ingredients
Present Administrative Appeal – 1st Instance - Pharmaceutical Ingredients
Obtain Certification of Good Manufacturing Practices for Pharmaceutical Ingredients
Obtain Certification of Good Practices for Distribution and Storage of Pharmaceutical Ingredients
Request transfer of ownership of Active Pharmaceutical Ingredient
Preparation and review of the technical dossier required for registration of Drugs with local regulatory body
Risk Analysis - Determine the correct classification of drugs 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
Change Certification of Good Manufacturing Practices for Drugs
Change Bioequivalence Center certification
Change clinical trial of advanced therapy products
Change leaflet text - Pharmacovigilance Request
Change notified medication regularization
Update Good Drugs Practice Certification
Cancel Good Manufacturing Practices Certification for Drugs
Cancel regularization of notified Drugs
Present a document describing the Pharmacovigilance System
File 1st Instance Appeal - notified Drug
Present Administrative Appeal – 1st Instance - Drugs and Biological Products
Present a periodic benefit-risk assessment report
Present result outside specification in approved DIFA stability study
Report reactivation of manufacturing/importation of Drugs
Consult sales data for controlled Drugs, antimicrobials and others
Report Drug safety – Pharmacovigilance
Issue a second copy of the Good Manufacturing Practices Certification for Drugs
Obtain Authorization to Export or import a controlled substance, plant or Drugs
Obtain authorization to carry out clinical trials of Drugs
Obtain Good Manufacturing Practices Certification for Drugs
Obtain Certification of Good Distribution and Storage Practices for Drugs
Obtain Registration of Generic, Similar, New and Innovative Drugs
Obtain authorization to purchase Drugs subject to special control (AMC)
Obtain Authorization for Compassionate Use, Expanded Access, and Post-Study Drug Supply
Renew Certification of Good Distribution and Storage Practices for Drugs
Renew Good Manufacturing Practices Certification for Drugs
Services for Cosmetics
Change authorization for an asset with a straightening or hair curling function
Change Certification of Good Manufacturing Practices for cosmetics
Change Cosmetics Registration
Drafting regulatory opinions
Risk Analysis - Determine the correct classification of cosmetics according to local regulatory body
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
Preparation and review of the technical dossier required for registration of Cosmetics with local regulatory body
File an Administrative Appeal in the 1st instance – Registered Cosmetics
File an Administrative Appeal in the 1st Instance – Notified Cosmetics
Update Good Cosmetic Practices Certification - corporate or commercial operations
Cancel Cosmetics Registration
Issue Cosmetics Registration Certificate (CVL)
Issue a second copy of the Certification of Good Manufacturing Practices for cosmetics
Obtain active authorization with straightening or hair curling function
Obtain Good Manufacturing Practices Certification for cosmetics
Regularization of Cosmetics Products Exempt from Registration
Renew Certification of Good Manufacturing Practices for Cosmetics
Renew Cosmetics Registration
Request re-registration of Cosmetics exempt from registration
Request Cosmetics Registration
Request transfer of cosmetic ownership
Services for Sanitizers
Change Certification of Good Sanitizing Manufacturing Practices
Change registry of sanitizers
Change Regularization of Sanitizing Exempt from Registration
File Administrative Appeal - 1st Instance - Sanitizing
Update Certification of Good Sanitizing Practices - Corporate or Commercial Operations
Preparation and review of the technical dossier required for registration of Sanitizers with local regulatory body
Risk Analysis - Determine the correct classification of sanitizers according to local regulatory body
Cancel registration of sanitizers
Cancel Regularization of Sanitizing Products Exempt from Registration
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
Communicate the manufacture of exclusive sanitizer for export
Issue a sanitizing Registration Certificate
Issue Certificate of Regularization of Exempt Sanitizing Products
Issue duplicate of the Certification of Good Sanitizing Manufacturing Practices
Manifest Interest in Continuing to Trade Sanitizing Products Exempt from Regularized Registration
Obtain Sanitizing Good Manufacturing Practices Certification
Renew Certification of Sanitizing Good Manufacturing Practices
Renew sanitizing registration
Request alteration of asset monograph - Household Sanitary Use
Request New Asset Authorization for Household Sanitary Use
Request Registration of Risk Sanitizers
Request Regularization of Sanitizing Products Exempt from Registration
Request Transfer of Sanitizing Ownership
Services for Medical Cannabis
Assistance in obtaining GACP Licenses
Request Regularization of Cannabis Products
Good Manufacturing Practice (GMP) Compliance Assessment
Good Distribution Practice (GDP) Compliance Assessment
Good Laboratory Practice (GLP) Compliance Assessment
Auditing and qualification locally
Creation of QMS of procedures and operations
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
File an administrative appeal in the 1st instance – Regularization of Cannabis-based products
Request Change to Cannabis Products
Submit Cannabis Product Analytics Data
Request authorization to import Cannabis-derived products
Request Cancellation of Cannabis Products
Services for Companies
Opening and regulating a company
Supplier auditing and qualification
Advice on Good Distribution and Storage Practices
Preparation of Standard Operating Procedures
Analysis of Health Surveillance reports
Drawing up action plans
Training in good health practices
Reviewing health documents and records
Assumption of Technical Responsibility
Licenses from environmental agencies
Clarifying technical doubts
Preparation of a response dossier to the Health Surveillance Agency
Special Authorization (AE)
Monitoring corrective actions
Health inspections and licenses
Licenses for pharmacies and drugstores
Training in good health practices
Review of health documents and records
Management of intermediate processes for obtaining licenses
Evaluation of Training Documentation Requirements
Analysis of requirements for obtaining licenses
Guidance on physical adjustments and infrastructure
Management of internal audits and inspections
Updating and monitoring health legislation
Guidance on proper waste disposal
Quality Assurance Services
Quality Management Systems (QMS)
SOP development
Audits and Mock-up inspections
Good Distribution Practices
Regulatory Agency Response
Preparation and Trainning
Inspection Readiness
Surveillance of Medical Devices
Pharmacovigilance
Cosmetovigilance
Nutrivigilance
Strategy, implementation and quality improvement
CAPA, Investigations and deviations support
Good Documentation Practice
Good Manufacturing and Laboratory Practices
New product design control support
Technical Writing
ISO 13485:2016 QMS
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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