Simplify Your Regulatory Path in Brazil with Brisa's BPO Services

A Comprehensive, Cost-Effective Solution for Managing Your Regulatory Needs and Expanding Your Market Reach.

Schedule a Free Consultation

Brisa Advisors has been trusted by leading Companies

EXCLUSIVE OFFER

Get 1 Year of Free Market Access in Brazil.

Register your medical device with Brisa’s BPO in Regulatory Affairs and connect with a network of over 3,5k hospitals and 100k+ users. Showcase your products in the thriving Brazilian medical market.

Brazil's Market: huge potential beyond complexity

Sure, stepping into Brazil’s market has its complexities — from intricate distributor networks, bureaucratic procedures, and compliance with ANVISA, INMETRO, ANATEL, and GMP certification.

But here’s the exciting part: with Brisa Advisors, these complexities become manageable. Our extensive experience, spanning nearly three decades in regulatory, governmental, and commercial domains, equips us to smooth out these hurdles, paving the way for your product’s successful market entry.

Brazil is the largest medical device market in Latin America, pulsating with growth and opportunity. The demand for top-notch healthcare solutions is skyrocketing, creating a fertile ground for manufacturers ready to make a mark.

BPO in RA

Business Process Outsourcing in Regulatory Affairs

Complete Regulatory Coverage

All-inclusive package for medical device registration and maintenance.

Significant Savings

Fixed annual fees that eliminate budget surprises.

Simplicity and Convenience

One partner for all your regulatory requirements.

Free Market Access

One year of free access to our NonStop platform, connecting you with over 3,5k hospitals and 100k+ users.

What We Offer

Regulatory Compliance Assessment

Thorough evaluation of your documentation for compliance.

Dossier Preparation and Submission

Professional preparation and submission to ANVISA.

Brazil Registration Hosting Service (BRHS)

Management of registrations and certificates.

Audit Follow-Up

Handling INMETRO and ANATEL audits.

Authorization Letters

Issuance of Letters of Importation for distributors.

Good Manufacturing Practices (GMP)

Application and renewal submission to ANVISA.

How It Works

Step 1

Initiate Service

Send the IFU to Brisa and receive the regulatory pathway with a quotation.

Step 2

Comprehensive Assessment

We assess and prepare all necessary documentation.

Step 3

Submission and Follow-Up

We submit your dossier to ANVISA and manage the process.

Step 4

Market Access

Gain immediate access to our NonStop platform for free.

Step 5

Continuous Support

Enjoy ongoing support for audits, compliance, and market expansion.

Testimonials

Learn what it's like to work with Brisa from our clients

"The partnership between Organ Recovery Systems and Brisa is now 11 years old, starting when it was still Brasil Import/Emergo. It has worked on the approval of all ORS products with ANVISA and has followed up on regulatory requirements, always anticipating possible adjustments to the good practices of the factories in the United States, meeting the regulatory demands required by the Health Surveillance Agency. The work, which often requires specialized human resources and represents an additional cost to the operation, was carried out with expertise and with controlled and predictable costs. But the most important part for me was the atmosphere of professionalism, mutual trust and absolute respect built up over these years of partnership. Not to mention that the current service outsourcing model - BPO in RA, a kind of monthly service subscription - represents a breakthrough in cost control and in the agility of the service provided."

"Our company has a big challenge in Brazil, we started from scratch all the regulatory processes in the country: INMETRO and ANATEL certifications, Brazilian Good Manufacturing Practices, and ANVISA registrations. We are under the BPO in RA with Brisa, it was an excellent choice for Lumenis Be since Brisa guides us professionally in these regulatory steps. The Brisa team answers our questions and doubts daily, they give us enormous support to make decisions and plan our regulatory strategy in this country; we trust their suggestions and experience."

"Comprehensive experience with and understanding of Brazil regulatory and reimbursement law and practice. Expertise in helping companies with strategy, planning, and navigating the complex process of securing new regulatory product registrations and product renewals Has long-standing professional relationships with the Brazil national regulatory and reimbursement administrations and community of specialist regulatory law attorneys and technical advisors Accessible, responsive, ethical, practical, innovative, hard working, Advice that can be trusted; no sugar coating or telling clients what they want to hear. Capability to provide realistic assessments of technical process requirements and timetable for development and prosecution of regulatory filings."

“I recognize your excellent and professional competence in national and international regulatory field based on your personal skills and from the long history of experience. A competent and professional service, not only business and/or commercial own oriented, which can support company as part of their internal team in the business strategy to penetrate as far as possible the international markets by obtaining the proper authorizations with the respect of legislations and Company ‘goals and timing. Expert, Results-driven, Professional."

Ready to Streamline Your Regulatory Affairs?

Who we are

Welcome to Brisa Advisors, where navigating the complex world of Regulatory Affairs becomes a seamless journey. For years, we have been the trusted partner for medical device manufacturers around the globe, ranging from small innovative startups to industry giants like Colgate Palmolive, Hoechst, Bayer, Sumitomo, and the TELEFLEX group.

We pride ourselves on our comprehensive expertise across diverse sectors. Whether it’s pharmaceuticals, food products, sanitizers, cosmetics, or primarily, medical devices, our strategic approach and deep understanding of the regulatory landscape ensure our clients success. Our extensive experience with ANVISA, the Brazilian Health Regulatory Agency, positions us uniquely to offer unparalleled insights and solutions.

Our mission is clear: to simplify the regulatory process for our clients, allowing them to focus on what they do best: innovate and grow.

Choosing Brisa Advisors means choosing a partner who is deeply invested in your regulatory success. We believe in building lasting relationships, and our clients’ achievements are a reflection of our own. Let us guide you through the regulatory maze with precision, expertise, and a strategic vision that sets you up for success.

Simplify Your Regulatory Path in Brazil with Brisa's BPO Services

Schedule a Free Consultation

Brisa Advisors has been trusted by leading Companies

EXCLUSIVE OFFER

Brazil's Market: huge potential beyond complexity

BPO in RA

Business Process Outsourcing in Regulatory Affairs

Complete Regulatory Coverage

Significant Savings

Simplicity and Convenience

Free Market Access

What We Offer

Regulatory Compliance Assessment

Dossier Preparation and Submission

Brazil Registration Hosting Service (BRHS)

Audit Follow-Up

Authorization Letters

Good Manufacturing Practices (GMP)

How It Works

Step 1

Step 2

Step 3

Step 4

Step 5

Testimonials

Learn what it's like to work with Brisa from our clients

Ready to Streamline Your Regulatory Affairs?

Who we are

BPO in RA

Contact

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