Food Supplements
Analysis of technical documentation against health requirements
Evaluation of specifications
Assistance in developing specification monographs
Regulatory assessment of the production process
Review of toxicological studies to determine safety
Guidelines for conducting toxicological studies
Review of clinical studies to determine efficacy
Guidelines for conducting clinical studies
Evaluation of formulas against health requirements
Review of labeling
Labeling design
Review of label artwork
Review of advertising materials
Drafting regulatory opinions
Clarifying technical doubts
Monitoring the regulatory horizon
Regulatory-strategic support
Drawing up documentation checklists
Gap analysis
Preparation of feasibility reports
Preparation of weakness reports
Regulatory support for food imports
Regulatory support for food exports
Preparation and review of the technical dossier required for registration of companies with local regulatory body
Issuing health licenses/permits
Submitting consultations on new foods to local regulatory body
Notice of start of import
Manufacturing start notice
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
Support for addendum protocols
Protocol for withdrawal requests
Assistance with confidentiality of local regulatory body opinions
Review of evaluation, communication, notification and registration processes
Preparation of administrative appeals
Assistance in drafting responses to notifications and health infringements
Courses on regulatory requirements
Training on regulatory requirements
Assistance in setting up and maintaining a post-market monitoring system
Assistance in drawing up and maintaining a product recall plan
Medical Devices
Risk Analysis - Service to help determine the correct classification of medical devices 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
Strategic Regulatory Planning
Regulatory Impact Assessment
Good Manufacturing Practice (GMP) Compliance Assessment
Label and Packaging Review
Advice on Complaints and Recalls
Preparation and review of the technical dossier required for registration of medical devices with local regulatory body
Analysis of Clinical Studies
Verification of Labeling Requirements
Evaluation of Registration Documents obtained in other countries
Analysis of accessory labeling requirements
Advice on Testing and Certification
Assistance in obtaining Local Regulatory Body Certification
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
Drugs
Change Certification of Good Practices for Distribution and Storage of Pharmaceutical Ingredients
Change Certification of Good Manufacturing Practices for Pharmaceutical Ingredients
Change Active Pharmaceutical Ingredient Registration
Present Administrative Appeal – 1st Instance - Pharmaceutical Ingredients
Update Certification of Good Practices for Pharmaceutical Ingredients - corporate or commercial operations
Cancel Registration of Active Pharmaceutical Ingredient
Obtain Certification of Good Manufacturing Practices for Pharmaceutical Ingredients
Obtain Certification of Good Practices for Distribution and Storage of Pharmaceutical Ingredients
Renew Certification of Good Manufacturing Practices for Pharmaceutical Ingredients
Request transfer of ownership of Active Pharmaceutical Ingredient
Preparation and review of the technical dossier required for registration of APIs with local regulatory body
Change Certification of Good Manufacturing Practices for Drugs
Change Bioequivalence Center certification
Change clinical trial of advanced therapy products
Change advanced therapy product registration
Change notified medication regularization
Change leaflet text - Pharmacovigilance Request
Preparation and review of the technical dossier required for registration of Drugs with local regulatory body
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
Update Good Drugs Practice Certification - corporate or commercial operations
Cancel Good Manufacturing Practices Certification for Drugs
Cancel regularization of notified Drugs
Report definitive discontinuation of Drugs
Report temporary discontinuation of Drugs
Report reactivation of manufacturing/importation of Drugs
Consult sales data for controlled Drugs, antimicrobials and others
Issue a second copy of the Good Manufacturing Practices Certification for Drugs
Report Drug safety - Pharmacovigilance
Obtain Authorization to Export or import a controlled substance, plant or Drugs
Obtain authorization to carry out clinical trials of Drugs
Obtain authorization to purchase Drugs subject to special control (AMC)
Obtain Authorization for Compassionate Use, Expanded Access, and Post-Study Drug Supply
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
Renew Certification of Good Distribution and Storage Practices for Drugs
Renew Good Manufacturing Practices Certification for Drugs
Cosmetics
Change authorization for an asset with a straightening or hair curling function
Change Certification of Good Manufacturing Practices for cosmetics
Change Certification of Good Manufacturing Practices for Health Products
Change Cosmetics Registration
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 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
Issue Cosmetics Registration Certificate (CVL)
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
Cancel registration of sanitizers
Cancel Regularization of Sanitizing Products Exempt from Registration
Communicate the manufacture of exclusive sanitizer for export
Preparation and review of the technical dossier required for registration of Sanitizers with local regulatory body
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
Medical Cannabis
Assistance in obtaining GACP Licenses
Preparation and review of the technical dossier required for registration of Cannabis Products with local regulatory body
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
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
Opening and regulating a company
Evaluation of Training Documentation Requirements
Advice on Good Distribution and Storage Practices
Supplier auditing and qualification
Health License
Preparation of Standard Operating Procedures
Analysis of Health Surveillance reports
Drawing up action plans
Monitoring corrective actions
Preparation of a response dossier to the Health Surveillance Agency
Training in good health practices
Reviewing health documents and records
Guidance on proper waste disposal
Health inspections
Assumption of Technical Responsibility
Licenses from environmental agencies
Licenses for pharmacies and drugstores
Analysis of requirements for obtaining licenses
Guidance on physical adjustments and infrastructure
Training in good health practices
Review of health documents and records
Management of internal audits and inspections
Updating and monitoring health legislation
Management of intermediate processes for obtaining licenses
Quality and Assurance
Quality Management Systems
Good Distribution Practices
Audits
Surveillance of Medical Devices
Pharmacovigilance
Cosmetovigilance
Nutrivigilance
Good Manufacturing and Laboratory Practices
Quality Management Systems (QMS)
INMETRO certifications
ISO certification
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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