Regulatory and Technical Strategies to improve the quality of dossiers presented to ANVISA and accelerate approvals.
Techniques for the regulatory evaluation of analytical validation reports and strategies for reducing queries at registration and post-approval petitions.
Techniques for the regulatory evaluation of process validation reports, preparation of summary as per Anvisa's templates and reduction of queries registration and post-approval petitions.
Classification, Risk Analysis and preparation of PATE. Understanding the mechanism and preparing the team for the implementation and approval of requests for post-approval variations.
New Biological Products and Biosimilars : concepts, techniques and regulatory strategies to improve the submission of M.A. dossiers and post-approval variations.
Market, regulation, licenses and everything a company needs to know from the regulatory point of view to start its activities in Brazil.
Concepts, evaluation, elaboration and submission of M.A. dossiers as per Anvisa guidelines for CTD application.