Would you like to register your product in Brazil?

Auditoria:
22/05/2019
Quer registrar seu medicamento no Brasil?
05/06/2019

Phartrials makes the regulatory evaluation of your drug documentation for submission of the registration dossier in accordance with Brazilian guidelines (Anvisa).
• Evaluation (or execution) of safety and efficacy report;
• Evaluation (or execution) of non-clinical trials;
• Evaluation (or execution) of Phase I, II and III clinical trial report;
• Evaluation of DMF according to current guidelines;
• Evaluation of finished product technical report;
• Evaluation of the pharmacovigilance plan, pharmacovigilance report and risk minimization plan;
• Evaluation of the relative bioavailability study.

Our advantages:
• Team formed by specialists, masters and doctors with experience in the scientific and regulatory area;
• Safe and accurate information that complies with Brazilian legislation;
• Reports based on references recognized by the national and international scientific community;
• Compliance with deadlines;
• Technical discussions with ANVISA in all projects executed;

Contact us
cleverson@phartrials.com.br

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