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

Would you like to register your product in Brazil?

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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