Mind the Gap
In-depth document analysis of M.A. applications and post-approval dossiers. Determination of technical and regulatory compliance. Risk mitigation.
Evaluation of DMFs.
Registration of pharmaceutical active ingredients (APIs). Adequacy to the new regulatory pathway (DIFA and CADIFA).
Writing, organization, elaboration, assembly and submission of marketing authorization dossiers.
Preparation and submission of protocols (DDCM and DEEC). Compassionate use and expanded access programs.
Writing and assembling CTD dossiers for drug product approval and and post-approvals based on the recommendations of the ICH and the requirements of Anvisa Guide 24/2019.
Strategy, elaboration, assembly and submission of post-approval processes, PATE, HMP/APR and Transference of M.A. ownership.