MARKETING AUTHORIZATION APPROVALS

AND LIFE CYCLE MANAGEMENT

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GAP ANALYSIS

In-depth document analysis of M.A. applications and post-approval dossiers. Determination of technical and regulatory compliance. Risk mitigation.

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APIs

Evaluation of DMFs.

New excipients.

Registration of pharmaceutical active ingredients (APIs). Adequacy to the new regulatory pathway (DIFA and CADIFA).

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M.A. DOSSIERS

Strategic support.

Writing, organization, elaboration, assembly and submission of marketing authorization dossiers.

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CLINICAL TRIALS

Clinical strategy.

Preparation and submission of protocols (DDCM and DEEC). Compassionate use and expanded access programs.

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CTD

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.

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POST-APPROVALS

Strategy, elaboration, assembly and submission of post-approval processes, PATE, HMP/APR and Transference of M.A. ownership.