BPO in RA

Experts in Brazilian Medical Device Registrations

We are a Regulatory Affairs Consulting Company specialized in the Brazilian market.

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Brisa Advisors has been trusted by leading Companies

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Years Experience

ABOUT BPO in RA

Business Process Outsourcing in Regulatory Affairs

“Brazil isn’t for amateurs”
– Famous quote from Tom Jobim
Author of the song The Girl from Ipanema.

That’s why you need BPO in RA.

Business Process Outsourcing in Regulatory Affairs is an annual subscription service for the complete management of Regulatory Affairs with ANVISA, in Brazil.

We offer everything that a regulatory department can provide, without the hassle of having to manage people and processes in a market with a different culture than the contracting company.

Team of excellence

You will have access to a complete RA team

RA DIRECTOR

With almost 30 years' experience in the Brazilian market.

TECHNICAL CONSULTANT

Specialized in your product.

PROJECT MANAGER

Ensuring focus on deadlines, time savings and effective communication.

OPERATIONAL TEAM

To issue import authorizations and other services such as post-market control.

We Offer

Immeasurable benefits for your business

Time savings

In the bureaucratic stage of issuing a proposal, contracting, and exchanging unnecessary information.

Budget predictability

Hiring a BPO in RA through a subscription service reduces costs and allows you to really know how much will be spent in the year with AR, without surprises.

Compliance

Direct import hospital x manufacturer eliminates the possibility of non-compliance with the Foreign Corrupt Practices Act (FCPA).

Availability

There is no removal of the employee due to health reasons, maternity leave, or even job rotation.

Reducing risks

Avoids labor costs and eventual legal claims.

Know-how

General Director with 30 years of experience, including working in multinational companies, deep knowledge of the market with legal, regulatory, and commercial vision.

Brazil is a complex market

Accessing this market can be complex and costly. However, with BPO in RA, we are able to devise the best strategy for overcoming any difficulties.

Problems with distributors, the tax system, imports, bureaucracy, ANVISA, INMETRO, ANATEL, GMP certification – these are some of the main difficulties faced by foreign medical device manufacturers.

With almost 3 decades of knowledge in the regulatory, governmental and commercial areas, Brisa Advisors has broken down these barriers and helped its clients get their product to market.

Trust & Security

Integrity & Commitment

BRISA ADVISORS

Who we are

Brisa Advisors, a Regulatory Affairs consulting company, has acted for dozens of small, medium, and large international medical device manufacturing companies before ANVISA, such as Colgate Palmolive, Hoechst, Bayer, Sumitomo, and TELEFLEX group.

Acted in the areas of drugs, food, sanitizing products, cosmetics, and mainly medical devices. It stood out in the first merger case in which they acted to change the understanding of the legislation in force, motivating the change of the regulatory framework of ANVISA.

The change provided significant savings to its client in the payment of fees to ANVISA.

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."

"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."