Our services
Regulatory Affairs in Central America and the Dominican Republic.
- Marketing Authorization Approval (MAA)
- Dossier preparation and follow-up until approval
- Technical and Legal Translations
- Regulatory Advisory and Intelligence
- Post Approval modifications
- Coordination of Regional Projects
- Trademark Registration
- Health Licenses for Establishments
Marketing Authorization Approval for:
Drug products
Biological products
Cosmetics
Processed foods
Infant formulas
Medical Devices
Nutritional supplements
Other Services
- Regulatory Affairs Counseling: Design and implementation of regulatory strategy
- Technical translations of dossiers (English-Spanish) carried out by professionals
- Trade mark registration
- Regulatory Intelligence: We provide periodic updates, so that you know the regulatory requirements applicable to your portfolio, and knowledge about the expectations of the regulatory authorities. All in your own language.
- Sanitary licenses: opening of drugstores and distributors. Service available in Guatemala.
How can we support you?
We offer services in:
Guatemala
El Salvador
Honduras
Nicaragua
Costa Rica
Panama
Dominican Republic
