The diligent consulting that your company deserves.

TM RA Consultancy is a distinguished consultancy firm specializing in regulations for Active Pharmaceutical Ingredients (APIs) in Brazil. Let us guide you through the Brazilian API legislation.

About us

Facilitating processes. Ensuring health.

Our unwavering commitment to regulatory excellence sets us apart in the industry. We offer tailored solutions for international companies seeking to navigate the stringent regulatory landscape of the API Brazilian market.

Our services

How we will assist you

Our team is qualified to provide customized services to support your company during all the processes involving API registration and maintenance of the certifications required, facilitating processes, and ensuring health.

CBPF Dashboard

Designed to enhance the connection between API manufacturers and Brazilian pharmaceutical companies.

CADIFA Lifecycle

Our highly qualified team is dedicated to providing essential support post-approval of CADIFA.

CADIFA Application

We are dedicated to providing extensive assistance for your CADIFA application.

CBPF Application

We provide a comprehensive CBPF application service, offering the necessary support throughout the entire process.

Response Application

Our highly qualified team stands by your side, providing essential support in the event of receiving a deficiency letter from ANVISA.

Quality Assurance Audit

Our services guarantee that your pharmaceutical operations maintain the highest quality and regulatory compliance Anvisa requires.

Training in Brazilian
Pharmaceutical Legislation

Our training goes beyond theory, combining practical insights with in-depth knowledge of Brazilian pharmaceutical legislation.

Let's talk about how we can assist your company to thrive in the Brazilian market.

News

Recent Posts

Anvisa has published the English version of Normative Instruction 289/2024!

IN 289/2024 outlines the criteria for the optimized analysis procedure, which relies on assessments by Equivalent Foreign Regulatory Authorities (AREE) for the registration and post-registration of medicines, biological products, vaccines, and Active Pharmaceutical Ingredient Dossier (CADIFA).

We Are Live! Unlock New Opportunities with the CBPF Dashboard

We are thrilled to announce that the CBPF dashboard is now live! Designed to enhance the connection between API manufacturers and Brazilian pharmaceutical companies, this innovative tool will not only boost the visibility of API manufacturers in the Brazilian market but also streamline the sourcing process for drug manufacturers seeking reliable API suppliers.

CBPF publication – ANVISA Official Gazette of August 12, 2024.

Check the API manufacturing companies that received CBPF (GMP) from ANVISA this week. The document includes certification issued to biological, semisynthetic, and synthetic API manufacturers—data source: National Health Surveillance Agency – Official Gazette.

Coming Soon: Launch of the CBPF Publications Dashboard

We are pleased to announce that we will soon be launching a new dashboard dedicated to the publications of Good Manufacturing Practices Certificates (CBPF) issued by Anvisa. This new resource has been developed to facilitate access to information and quickly find specific API and certified manufacturers.

CBPF publication – ANVISA Official Gazette of August 5, 2024.

Check the API manufacturing companies that received CBPF (GMP) from ANVISA this week. The document includes certification issued to biological, semisynthetic, and synthetic API manufacturers—data source: National Health Surveillance Agency – Official Gazette.

CBPF publication – ANVISA Official Gazette of July 29, 2024.

Check the API manufacturing companies that received CBPF (GMP) from ANVISA this week. The document includes certification issued to biological, semisynthetic, and synthetic API manufacturers—data source: National Health Surveillance Agency – Official Gazette.