When Holder Service is the Best Strategy?

Holder Service, or International Hosting, is a service provided by a duly registered Brazilian company that grants its license and Company Operating Permit (AFE) to ANVISA so that a foreign company can register and import its products. This solution stands out in three main situations:

• Market Testing and New Product Launch: For startups and companies that want to validate the acceptance of a product in Brazil without committing to large initial investments, Holder Service is the ideal tool. It allows for quick entry, providing real market data that informs future decisions about heavier investments, such as opening a subsidiary.
• Focus on Core Business without Bureaucracy: Companies that want to concentrate their resources on innovation, production, and international marketing, outsourcing local regulatory complexity, find Holder Service to be the perfect solution. It transforms a process that could take years into a matter of months, freeing up staff for strategic activities.
• Commercial Control without Ties to Distributors: Unlike an exclusive distribution agreement, where a foreign company can become hostage to a single partner, the Holder Service model guarantees total freedom. The company retains ownership of the registration and the autonomy to choose and change as many importers and distributors as it deems necessary, optimizing its sales network according to performance.

HOLDER SERVICE IS IDEAL FOR ME

Choosing Holder Service translates into tangible financial and operational benefits that directly impact return on investment and speed of market gain.

• Radical Reduction in Costs and Time: The traditional way of opening a company in Brazil involves costs related to physical structure, accounting, various taxes, and hiring personnel. With Holder Service, these costs are eliminated. The waiting time to market products, which can take from a year and a half to two years, is drastically reduced to approximately four to six months.
• Mitigation of Regulatory and Operational Risks: BRH, thanks to its expertise, knows the ins and outs of ANVISA's processes. This significantly reduces the risk of registration being rejected due to documentation errors or ignorance of specific technical requirements, a high risk for those unfamiliar with Brazilian regulatory day-to-day operations. In addition, the foreign company is protected from the exchange rate risks and tax complexities inherent in operating a legal entity in Brazil.
• Scalability and Flexibility for Growth: The model is intrinsically scalable. As the foreign company's product portfolio grows, or as demand in the Brazilian market increases, Holder Service allows new registrations to be added and import volumes to be expanded without the need to expand a local physical or administrative structure, keeping pace with growth in an agile and efficient manner.

I WANT TO HAVE A COMPETITIVE ADVANTAGE

It is natural to have doubts about adopting a model that, at first glance, appears to transfer part of the control. However, a more in-depth analysis shows that the risks are manageable and the benefits are greater.

• “Will I lose control over my registration and my brand?” → No. In a well-structured Holder Service partnership, the foreign company is the owner of the product registration. BRH acts as the “legal representative” before ANVISA, but the intellectual and commercial property of the product is retained by the foreign company. This is a relationship for the provision of specialized services, not a transfer of ownership.
• "Will I become dependent and ‘stuck’ with a single partner?" → Not necessarily. A good Holder Service contract should include transition and portability clauses that guarantee the foreign company the necessary security. In addition, the very nature of the service gives you the freedom to manage the distribution chain. Dependency exists, but it is a strategic and managed dependency, similar to that of any other critical service provider.
• "What if the BRH is unreliable or has its license revoked?” → This is a critical but avoidable risk. The solution lies in due diligence. It is essential to hire a well-established BRH with a proven track record, up-to-date licenses, and a high rate of case approval. Reputable companies are transparent about their regulatory status and offer full access to case progress.

Taming ANVISA bureaucracy safely and quickly requires a partner that goes beyond simply submitting documents. You need an ally with hands-on experience, solid licenses, and a strategic vision for your business. Stone Okamont fills this role, offering a partnership that simplifies entry into Brazil.

We are a Brazilian Registration Holder (BRH) with a valid Operating License and Company Operating Authorization (AFE), which allows us to be the legal basis for the regularization of your products. Our qualified team works in an integrated manner, ensuring that each step, from initial registration to post-market management, is conducted with maximum efficiency and compliance. Choosing Stone Okamont means choosing a direct and safe path, where regulatory complexity is transformed into a simple operational step, allowing you to focus on what really matters: developing and selling your product.