How Stone Okamont can facilitate product registration with ANVISA?

The first and biggest obstacle in registering with ANVISA is preparing the technical-regulatory dossier. The required documentation is extensive and highly specific, varying according to the type of product—whether it is a drug, a grade 2 cosmetic, a medical device, or a food with functional property claims. An error in product classification, safety and efficacy testing, or the presentation of stability studies can result in rejection or a requirement to return the process to square one, costing months of waiting.

Stone Okamont has been operating since the initial phase with an exclusive and personalized analysis of the client's project. The company applies its regulatory intelligence to guide the correct classification of the product and the accurate compilation of all necessary technical documentation. This preventive advice is crucial for identifying and remedying potential flaws before submission, exponentially increasing the chances of a swift and successful review by ANVISA, minimizing the risk of rework and extra costs.

REGISTER YOUR PRODUCT WITHOUT BUREAUCRACY

Even with a technically flawless dossier, companies face the operational complexity of the system. The protocol, monitoring deadlines, responding to requirements, and interacting with ANVISA analysts require time and procedural knowledge that many companies do not have internally. It is common for processes to be stalled due to simple ignorance of a step or suboptimal communication with the agency.

This is where the Zero Bureaucracy method, developed by Stone Okamont, shows its practical value. The company does not limit itself to consulting; it takes on the entire operational management of the process. This includes the final preparation of the bureaucratic process, personal protocol with ANVISA, and active monitoring of the entire development until the desired publication of the authorization in the Federal Official Gazette. Stone Okamont acts as a direct intermediary with the agency, monitoring deadlines, responding to any questions quickly and in appropriate technical language, and ensuring total transparency for the client at every stage. This proactive management is one of the main factors in significantly reducing the total processing time.

I WANT TO LEARN ABOUT THE ZERO BUREAUCRACY METHOD

The scope of Stone Okamont's services goes beyond standard product registration, addressing complex demands that are common in the current regulatory landscape. For international companies wishing to enter the Brazilian market, the regulatory barrier is even greater. It is necessary to understand not only ANVISA rules, but also how to adapt global quality systems, prepare for inspections, and deal with the local legal representative (Brazilian Registration Holder - BRH).

With global operations and the promotion of borderless relationships, Stone Okamont offers specialized support for these cases. The company provides Holder Service (International Product Hosting), acting as a qualified legal representative for foreign companies. In addition, it offers advice on monitoring ANVISA inspections and audits and on harmonizing international quality systems with the Brazilian agency's requirements. This comprehensive support allows companies from anywhere in the world to conquer the Brazilian market with agility, legal certainty, and full compliance.

I WANT STRATEGIC SUPPORT  

In an environment where delays in registration approval mean lost market opportunities and competitiveness, attempting to tackle ANVISA's complexities alone can be a considerable operational and financial risk. Regulatory expertise ceases to be a cost and becomes an essential strategic investment for the agility and security of your business.

Stone Okamont positions itself as a trusted partner and a true extension of your regulatory team. With a methodology focused on eliminating bureaucratic obstacles and a genuine commitment to the best cost-benefit ratio for each client profile, the company offers the clarity and efficiency your company needs to innovate with confidence. By delegating the entire regulatory role to Stone Okamont, your company gains time to focus on what really matters: developing, producing, and marketing with the certainty that compliance is being managed by those who understand the subject best.