MARKETING AUTHORIZATION APPROVALS

AND LIFE CYCLE MANAGEMENT

GAP ANALYSIS

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

APIs

Evaluation of DMFs.

New excipients.

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

M.A. DOSSIERS

Strategic support.

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

CLINICAL TRIALS

Clinical strategy.

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

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.

POST-APPROVALS

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

Address:

WT Morumbi 

Av. das Nações Unidas, 14261 - Block A

São Paulo / SP

BRAZIL

Phone:

(+55 11) 99420-1726 / (+55 11) 99483-0623

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