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