Freyr Expertise
- Regulatory Affairs Consulting and Pharmaceutical Market Access
- Legal Representation Service for foreign companies
- End-to-end Pharmaceutical Products Registration
- Authorized local agent support
- Pharma GMP Compliance Support
- Dossier Gap Analysis as per COFEPRIS Regulatory Requirements
- Preparation of Gap Analysis Report and Amendment Plan
- Pharmaceutical Dossier Preparation and Submission before COFEPRIS
- Query Support Management
- Regulatory Affairs Services
- Pharmaceutical Products Lifecycle Management Support
- Pharmaceutical Artwork Management
- Ad-hoc Mexico Regulatory Consultation
- End-to-end Support in Registering Herbal Medicines
- End-to-end Support for Herbal Remedy Products
- Post Marketing Surveillance Services (Pharmacovigilance)
Freyr Expertise
- Regulatory affairs and market access consulting for medical devices in Mexico
- Preliminary product classification according to intended use and risk
- End-to-end medical device registration
- Support for local agents
- Gap analysis of regulatory dossiers against COFEPRIS requirements
- Preparation of the Gap Analysis Report and Remediation Plan
- Preparation of the regulatory dossier and submission to COFEPRIS
- Regulatory services in Mexico
- Management and support for regulatory inquiries
- Product lifecycle management support
- Artwork management
- Ad-hoc regulatory consultations
- Post Marketing Surveillance Services (Technovigilance)
Freyr Expertise
- Legal Representation Service
- Formula and labeling assessment
- Advertising notice
- Support and advise on Verification Visit for Good Manufacturing Practices Compliance for local companies
- Obtaining a Certificate of Compliance for Cosmetic Labeling by Accredited Verification Units
Freyr Expertise
- Support in Submitting Consultation, Notice of Operation, and Import Permit for Food Supplements
- Food Product Compliance and Classification
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Dossier Compilation and Submission to the Health Authority (HA)
- Regulatory Intelligence (RI) Report
- Legal Representation (LR)