At TM RA Consultancy, our commitment to your regulatory success extends throughout the entire lifecycle of your CADIFA.
Our highly qualified team provides essential support post-approval of CADIFA. This comprehensive support includes meticulous categorization of all changes in accordance with current regulations. We also conduct thorough assessments of the necessary documentation, handle the completion of forms and declarations, and closely monitor notifications from Anvisa related to the process. We aim to ensure that every regulatory requirement is met with precision.
Our specialized services encompass:
- Categorization of Changes Related to CADIFA: We diligently categorize changes, ensuring they align with the requirements of Brazilian legislation.
- Development of Technical-Regulatory Documentation: We assist in creating the technical-regulatory documentation necessary for the change protocol by the API manufacturer, as stipulated by Brazilian legislation.
- Change Submission to Anvisa: Our support extends to the submission of the documentation related to the change on Anvisa’s system, ensuring a streamlined and compliant process.
With TM RA Consultancy, you can be confident that your CADIFA lifecycle is managed meticulously, guaranteeing ongoing compliance and success in the pharmaceutical industry.
