Members Area
WELCOME
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By becoming part of the TM RA Consultancy community, you will unlock access to opportunities and knowledge. As a member, you will have privileged access to all events organized by us, providing a comprehensive immersion into the regulatory universe. Additionally, we offer translations of the latest Brazilian resolutions applicable to Active Pharmaceutical Ingredients
RDC 672/2022
This resolution establishes criteria for the certification of Good Manufacturing Practices (GMP) and establishes the inspection program for international establishments manufacturing Active Pharmaceutical Ingredients (APIs).
Questions & Answers – Brazilian API Legislation CBPF and CADIFA
Check the Questions and Answers discussed in the Webinar Brazilian API Legislation on November 3rd. If you have any further questions, do not hesitate to contact us.
Webinar – Brazilian API legislation
Recording – Brazilian API Legislation Webinar, November 3, 2023.
RDC 359/2020 – CADIFA
This Resolution establishes the Active Pharmaceutical Ingredient Dossier (DIFA) and the Letter of Adequacy of the Active Pharmaceutical Ingredient Dossier (CADIFA).
It is applies to active pharmaceutical ingredients (APIs) used in manufacturing of new, innovative, generic and similar medicines.
