Brix Consulting
Gateway to Pharmaceutical Commercialization

The boom in the Latin American (LATAM) pharmaceutical economy and its substantial market size present an unprecedented opportunity for international life sciences companies to commercialize products. Yet, seizing this promising opportunity is often elusive for new entrants. It requires a profound understanding of complex regulations and the time and investment for reimbursement, licensing and approvals.

Brix Consulting serves as a compass, guiding companies in achieving a smooth and swift market entry into Brazil, Mexico, Colombia and Argentina. Its core expertise is rooted in crafting optimal market access strategies and executing them flawlessly.

“Companies are in a race when establishing their businesses in international markets, and we know how to expedite this process and help them enter in Brazil and other LATAM markets in a minimal timeframe possible,” says Karina Brito, founder and general manager, Brix Consulting.

Blueprint for a Subsidiary Setup

Brito brings over 15 years of experience in LATAM market access and regulatory affairs to help clients gain a foothold in key nations. Her knowledge is instrumental in meticulously tailoring the right insights and strategies to meet the demands of each market targeted for commercialization.

In the highly regulated LATAM pharma landscape, each regulatory and reimbursement agency has a distinct set of standards. Well-versed in the industry’s nuances, Brix helps companies set up their subsidiaries and become well-acquainted with the local regulatory compliance, technology and sales dynamics specific to each country. This process allows them to quickly secure local approvals and enhance long-term regional growth.

“Our ultimate goal is to deliver the product ready for commercialization.”

Collaborations with a vast and exclusive network of partners—law groups, tax agencies, distributors and other vendors—is a competitive advantage in establishing subsidiaries in LATAM.

When venturing into international markets, clients have three pathways. For those starting from scratch, Brix offers rental spaces in licensed warehousing for pharmaceutical products, allowing for independent distribution, and the services for obtaining the subsequence approvals.

The second model entails licensing the products for distribution without investing in rental spaces. Brix’s distribution partners take on the responsibility of marketing and selling in the target market.

In the third, a hybrid model, Brix or one of its partners is a market authorization holder, providing support in distribution as well as licensing and registering for warehouse operations on behalf of clients. Once the business expands, it is transitioned to independent distribution.

Brix presents these three commercialization alternatives in Brazil and other three countries: Argentina, Colombia and Mexico in LATAM region, outlining the benefits and drawbacks. It sets and executes the strategy that best fits the client’s business objectives. Drawing upon real-world examples to enhance client comprehension, it offers insights into similar products or companies that have already secured registrations, approvals or established themselves in the region.

Market Access Consulting with a Difference

Brix adopts a highly customizable approach in strategy consulting.

Its onboarding process begins with the fundamentals of the product(s) and company first approach to the target market, outlining the necessary documents and contracts to establish the client’s foundational structure. This includes detailing the timelines and associated costs for regulatory and reimbursement agencies to grant approvals in each country.

Brix’s consulting team sets an ideal strategy to introduce the product, consulting on one or more products to commercialize. It also determines whether clients wish to launch their products sequentially or simultaneously, across each country.

Companies are in a race when establishing their businesses in international markets, and we know how to expedite this process and help them enter in Brazil and other LATAM markets in a minimal timeframe possible

Subsequently, a procedural framework is designed to guide clients through the licensing procedures. Based on the power of attorney Brix is given, it operates with full trust and authority, ensuring that every step aligns with the client’s preferences and undergoes thorough approval and review.

A tax number is mandatory to establish subsidiaries in international countries. With proficient tax partners and streamlined processes, the Brix team procures the tax number within a month or so, laying the essential groundwork for clients.

On a parallel note, Brix resolves a crucial challenge in choosing between public and private healthcare systems for reimbursing pharmaceutical products. Through extensive market research and assessments, it recommends the most appropriate public or private systems, or both, to maximize the product’s chance of success in the LATAM markets.

When clients prioritize selling their products within clinical settings, Brix assists them in initiating name patient sales rather than promoting them directly to consumers or private healthcare providers.

Highlighting its versatility in addressing reimbursement hurdles is a scenario where a client who initially opted for the private system encountered a product denial. After examining its product models and economic factors, the consultants recommended switching to the public system. Even though the initial choice was a setback, with their expert guidance, the client successfully reimbursed its product.

Brix also deftly navigates pricing approvals in Brazil, Mexico, and Colombia. To release a new drug to the market, Brazilian authority requires price to be approved. In sequence, for reimbursement, the three nations have robust health technology assessment agencies that demand detailed economic data on budgetary considerations and impact assessments. Brix stands with the clients, presenting the essential documents to fulfill these requirements, leading the meetings with the involved agencies until securing the necessary approvals.

“Our ultimate goal is to deliver the product ready for commercialization,” says Brito.

Turning Challenges into Success Stories

In an implementation highlight, Brix helped a client holistically commercialize a diagnostic product in Brazil during the COVID-19 pandemic. Due to its injectable nature, regulatory agencies classified it as a medicine. The client gave Brix the power of attorney to set up the company, obtain the tax number, and secure necessary approvals.

Its consulting experts presented three potential models to the client, devising a tailored strategy for entering the Brazilian market. They created a comprehensive project plan and identified a suitable distribution space after an approval inspection visit by the client from abroad. All necessary licenses in compliance with Brazilian regulatory standards, including regulatory and pricing approvals were acquired.

Simultaneously, Brix developed connections with various manufacturing plants in Brazil to fulfill production requirements for that particular client. The client is currently selling its products to private clinics and working toward gaining public reimbursement.

Apart from catering to the end-to-end regulatory and market access needs, Brix’s distinctive skill set extends to providing specific assistance for clients. For example, a client was facing an issue with a private reimbursement agency that denied its product approval. The consulting team diligently re-evaluated the process and offered ideal recommendations, resulting in a remarkable turnaround of this denial into a favorable response.

Brix also resolved a situation where an agency misunderstood a client’s reference pricing for its product presented in a LATAM country. Facilitating meetings with the agency, its consultants identified the root causes of the misinterpretation. The outcome was a fair and desirable pricing approval for the client.

Many clients engage Brix to formulate international market strategies even during Phase III of clinical trials.

For instance, a U.S. company sought a strategy for launching and marketing its debut product overseas, including LATAM countries. Through a comprehensive product assessment, Brix gained insights into product attributes and healthcare regulations in the target nations. The devised strategy had a well-defined timeline of events. This enabled it to construct a proactive action plan for the client to accelerate regulatory approvals and swiftly enter these markets.

The Market Entry Maestros

The continued success is made possible by a passionate team of independent consultants, legal partners, distribution collaborators, expert pharmacists and health economists who work seamlessly to provide bespoke market access solutions. The firm ensures the right experts are assigned based on a project’s needs.

A defining factor is maintaining a structured communication cadence. Its full-time administrative professionals conduct bi-weekly meetings to inform clients of their project progress. They provide written reports with a comprehensive overview of project status and key insights during the alternative 15-day intervals.

When time-sensitive issues demand more attention, the project manager schedules additional meetings with clients to efficiently resolve them, fostering an open channel for real-time interactions.

Forging ahead with a stellar team, Brix has set sights on expanding its service footprint beyond USA and Europe, conquering clients into other international markets, which includes China, the Middle East, and Turkey. The recent admission of a new partner based in the USA will also make possible to help LATAM companies to have their strategy set to enter the U.S. market. This is certainly a huge step for Brix in offering its services for LATAM companies to reach the U.S. market.

Its distinct market insights and unmatched consulting acumen make Brix the preferred partner for global pharmaceutical, biotech, devices, and diagnostic companies looking to introduce their products and achieve unbeaten success in the lucrative LATAM markets.