AGENCIA DE ASUNTOS REGULATORIOS

SANITARY LICENSES, SANITARY REGISTRATIONS, AND CONSULTING

years of experience

Services

SANITARY REGISTRATIONS

  • Pharmaceuticals
  • Cosmetics
  • Medical Devices
  • Diagnostic Reagents
  • Hygienic / Hospital
  • Dental Supplements
  • Food Others

SANITARY LICENSES

  • Laboratories and Plants
  • Drugstores
  • Distributors
  • Fractionation
  • Pharmacies
  • Controlled Handling
  • Restaurants
  • Others

PHARMACO-TECHNOVIGILANCE

  • Local Responsibility

  • Official Notification

  • Centralized Source Data File

  • Literature Search and Management Plan Handling

  • Market Withdrawal

  • PSUR / CIOMS

  • Regulatory Compliance and Others

TECHNICAL-REGULATORY CONSULTING

  • Local Responsibility
  • Monthly Reconciliation
  • Literature Search
  • Management Plan
  • Handling
  • Official Notification
  • Risk Plan
  • Training
  • Others

LEGAL AND TRADEMARK CONSULTING

  • Legal and Regulatory
  • Legal Representation
  • Technical Management
  • Self-Inspections
  • Bids
  • Technical Talks
  • Regional Harmonization
  • Trademarks
  • Others

Service Territory

Our company offers services in multiple countries, providing global solutions tailored to local needs.

Guatemala

El Salvador

Honduras

Nicaragua

Costa Rica

Panama

Dominican Republic

Cuba

About Us

We are a Regulatory Affairs Agency, founded in 2004, that provides consulting services and manages SANITARY LICENSES in Guatemala and SANITARY REGISTRATIONS at a regional level: Central America and the Caribbean for establishments and products in the food, pharmaceutical, related (cosmetics, household hygiene, medical devices, diagnostic reagents, hospital hygiene, among others) and dental industries to obtain the necessary authorizations from the respective health authorities to carry out their commercial activities.

Satisfied Clients
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Sanitary Registrations
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Sanitary Licenses
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Consulting Services
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We Are Members

Being associated allows us to access up-to-date knowledge, strengthening and aligning us with the demands of the modern world, both regulatory and commercially.

Contact Us

Please contact us today for more detailed information about our services and how we can help meet your needs.