Mind the Gap
Marketing Authorization application for synthetic and semi-synthetic drugs.
Techniques and concepts to improve the quality of dossiers submitted to ANVISA and speed up approvals.
New Biological Products
regulatory concepts, techniques and strategies to improve the efficiency of M.A. submission and post-approval applications.
A regulatory analysis.
Techniques for the regulatory evaluation of analytical method validation reports and strategies to mitigate queries at M.A. application and post-approval variations.
Classification, Risk Analysis
Understanding the mechanism and preparing the team for the submission and approval of post-approval variations of synthetic and semi-synthetic drugs.
Concepts and techniques for evaluating, preparing, assembling and converting M.A. application and post-approval variations dossiers.
Techniques for regulatory assessment of process validation reports and preparation of the validation summary.
RDC 318/2019 and RDC 53/2015
Technical requirements and applicability.
How to evaluate reports and justifications from regulatory point of view.
RDC 359/2020 and 361/2020
New regulatory pathways for active pharmaceutical ingredients
Evaluation of DMFs,
risk mapping and strategies for regulatory submission.