Logotype TM RA Consultancy

您的公司应得的勤奋咨询。​

TM RA Consultancy 是一家杰出的咨询公司，专门从事巴西活性药物成分 (API) 法规的咨询。 让我们指导您了解巴西 API 立法。

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关于我们

促进流程。 确保健康。

我们对卓越监管的坚定承诺使我们在行业中脱颖而出。 我们为寻求应对 API 巴西市场严格监管环境的国际公司提供量身定制的解决方案。

了解更多关于我们的信息

我们的服务

我们将如何为您提供帮助

我们的团队有资格提供定制服务，在涉及 API 注册和所需认证维护、简化流程和确保健康的所有流程中为您的公司提供支持。

CBPF 仪表板

旨在加强 API 制造商和巴西制药公司之间的联系。

CBPF Dashboard

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

CADIFA 生命周期

我们的高素质团队致力于在 CADIFA 批准后提供必要的支持。
Response Application

响应申请

我们的高素质团队将站在您身边，在收到 ANVISA 的缺陷函时提供必要的支持。

质量保证审核

我们的服务保证您的制药业务保持 Anvisa 要求的最高质量和法规合规性。
CADIFA Application

卡迪法申请

我们致力于为您的 CADIFA 申请提供广泛的帮助。

CBPF申请

我们提供全面的 CBPF 申请服务，在整个过程中提供必要的支持。
Training in Brazilian Pharmaceutical Legislation

巴西语培训药品立法

我们的培训超越理论，将实践见解与对巴西药品立法的深入了解相结合。
CADIFA Lifecycle

CADIFA Lifecycle

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

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

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

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.

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新闻​

最近的帖子

CADIFA 2025 Seminar

Last Tuesday (November 18th), we had the privilege of participating in person in the CADIFA 2025 Seminar at Anvisa headquarters. The event aimed to present updates related to CADIFA.

Dashboard Updates

Our Dashboard just got an important update! In addition to information on manufacturers with CBPF, you can now also track CADIFA data – making it an even more complete tool to support strategic decisions in the Brazilian market.

Technical Note 34/2024 – CBPF certification for API manufacturers.

The Technical Note 34/2024, shared by Anvisa earlier this year, provides important clarifications regarding CBPF certification for API manufacturers. Are you familiar with how this information might impact your processes?

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 出版物 – 2024 年 8 月 12 日的 ANVISA 官方公报。

查看本周从 ANVISA 收到 CBPF (GMP) 的 API 制造公司。 该文件包括向生物、半合成和合成 API 制造商颁发的认证——数据来源：国家卫生监督局 – 官方公报。
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