Our multidisciplinary team of experts, comprising chemical engineers, pharmacists, and legal professionals, ensures seamless product registration with the highest standards of precision and compliance. We offer end-to-end support, covering everything from document preparation to regulatory approval and post-registration processes.

Partner with us to simplify your product registration, reduce delays, and achieve market entry with confidence and efficiency.

Product Registration

We develop personalized strategies to streamline the product registration process, enabling companies to navigate regulatory requirements with ease. Our goal is to expedite market access while maximizing approval success rates through efficient and compliant solutions.

Ready to bring your product to market? We guide you through the process:

Regulatory Affairs Procedure

Products requiring registration with ARCSA or AGROCALIDAD:

  • Pharmaceuticals
  • Medical Devices
  • Hygiene Products
  • Cosmetics
  • Veterinary Products
  • Agricultural Products
  • Food and Dietary Supplements

Holding and Management Service

In Ecuador, relying on local distributors as title-holders can backfire. They can seize control of your product registrations, forcing you into costly legal battles to regain ownership. This delays market entry and disrupts your operations.

By registering through Bermeo, a neutral third party, you maintain full control over imports, warehousing, and commercialization while complying with local regulations. Our services ensure risk mitigation, compliance, and flexibility to manage multiple distributors without compromise.

Difference between services:

Chart differentiating Holding and Management services

Regulatory Consulting

We provide customized solutions to support your product registrations, certifications, and regulatory needs throughout the lifecycle, including:

  • Efficacy Trials
  • Product Labeling
  • Scope Extensions
  • Renewals
  • Post-registration requirements (e.g., pharmacovigilance, agrochemical packaging disposals, etc.)

Other Certifications

  • Tittle-Holder Entity’s Operating Permits
  • Environmental Permits
  • Import Permits
  • Good Storage Practices (GSP)
  • Good Distribution Practices (GDP)

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Bermeo & Bermeo is the most efficient law firm in the country

We are proud to have been able to maintain our high standards from the inception of the firm and that our clients believe in our value propositions. The firm is stronger than ever, and rest assured our quality services will continue towards the future.