Freyr Expertise
- Regulatory Affairs Consulting and Pharmaceutical Market Access in Colombia
- Legal Representation Services for foreign companies
- End-to-end Pharmaceutical Products Registration before INVIMA
- Authorized local agent support
- Pharmaceutical GMP compliance support
- Dossier gap analysis in accordance with INVIMA regulatory requirements
- Preparation of gap analysis reports and amendment plans
- Pharmaceutical dossier preparation and submission before INVIMA
- Regulatory query support and authority interactions
- Regulatory affairs services
- Pharmaceutical product lifecycle management support
- Pharmaceutical artwork and labeling management
- Ad-hoc regulatory consultation in Colombia
- End-to-end support for herbal medicines registration
- End-to-end support for herbal remedy products
- Post-marketing surveillance services (Pharmacovigilance)
Freyr Expertise
- End-to-end Medical Device Services in Colombia
- Legal Representation Services for foreign companies
- Medical Device Sanitary Registration in Colombia before INVIMA
- Medical Device Regulatory Compliance in Colombia
- Application submission before INVIMA
- Regulatory query support management
- Post-approval medical device lifecycle management
- Import license services
- Artwork and labeling management
- Post-market surveillance services (Technovigilance)
Freyr Expertise
- Legal Representation Services
- Formula and labeling assessment
- Support and advisory services for verification visits related to Good Manufacturing Practices (GMP) compliance for local companies
- Advertising notice
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)